Job Description

Job Title: Head Manufacturing

Grade: 18
Department: Production
Reporting to: The Chairman
Bachelor's or Master's degree in Pharmacy, Chemical Engineering, or a related
Educational Qualification:
field. An MBA or advanced degree in Operations Management is advantageous.
1. Extensive experience in pharmaceutical manufacturing, with a focus on solid
dosage forms, injectables, or biologics.
2. In-depth knowledge of GMP, FDA regulations, and other relevant quality and
Work Experience:
regulatory standards.
3. Proven track record of successfully managing manufacturing operations,
delivering on production targets.

Key responsibilities:
1. Manufacturing Strategy and Planning:
a. Create and put into practise production strategies that are in line with the aims and objectives of the
company.
b. Develop production schedules, plans, and capacity utilisation techniques to make the most of available
resources and satisfy demand projections.
2. Production Management:
a. Track and evaluate production parameters including yield, cycle time, and downtime to spot problem areas
and put improvement measures in place.
b. Work together with cross-functional teams, such as those from supply chain, quality assurance, and
research and development, to guarantee a smooth production process and making sure they adhere to
GMPs and other legal and regulatory standards.
3. Quality Assurance and Compliance:
a. Create and maintain strong quality management systems to guarantee adherence to legal criteria such FDA
guidelines, GMP specifications, and ISO standards.
b. Put standard operating procedures (SOPs) into place and enforce them to guarantee constant product
quality and adherence to manufacturing methods.
4. Team Leadership and Development:
a. Build and manage a productive team while offering guidance, mentoring, and performance reviews.
Determine the staff's needs for training and offer them opportunities for professional growth.
b. Encourage a collaborative, accountable, and lifelong learning environment within the manufacturing
division.
5. Resource Management:
a. Control manufacturing spending and use resources wisely to meet output goals while staying within a
budget. Also, work with suppliers and procurement to guarantee a steady flow of supplies of equipment
and raw materials.
b. In order to promote innovation and operational excellence, evaluate and put into practice new technology,
tools, and production techniques.
Key Performance Indicators:
1. Improving the Production Output by increasing the Overall Equipment Efficiency (OEE), Production Yield, and
making the Production Cycle Time more efficient.
2. Monitoring Quality Management by validating/checking the First-pass Yield, Customer Complaint Rate, and
Corrective and Preventive Actions (CAPA) Effectiveness.
3. Effective Cost Management by monitoring the Overall Cost of Production, Cost per Unit, Cost Variance.
4. Improving Operational Efficiency by monitoring the Production Downtime, and Production Efficiency Ratio.
5. Ensuring 100% Regulatory Compliance in Audit Findings and Observations in matters, and Adherence to
Standard Operating Procedures (SOPs).

Competencies

Threshold Competencies Differentiating Competencies

Stakeholder Management: Proficiency in building and
Technical Expertise: A thorough understanding of
maintaining strong relationships with cross-functional
pharmaceutical manufacturing processes, equipment,
teams, senior management, regulatory bodies, and
and technologies is essential. This includes knowledge
external partners, effectively communicating and
of GMP regulations, quality standards, and industry
aligning manufacturing objectives with broader
best practices.
organizational goals.
Regulatory Compliance: Proficiency in navigating
Change Management: Ability to lead and manage
regulatory requirements, such as FDA regulations,
organizational change, adapt to new technologies and
GMP guidelines, and ISO standards, to ensure
processes, and drive a culture of continuous
manufacturing operations adhere to compliance
improvement and operational excellence.
standards.
Operational Efficiency: Demonstrated ability to Strategic Leadership: Proven track record of developing
optimize manufacturing operations, including and executing manufacturing strategies aligned with
capacity planning, resource allocation, and production organizational goals, driving innovation, and
scheduling, to meet demand and maximize efficiency. anticipating industry trends.
Quality Management: Strong knowledge of quality Talent Development: Experience in talent acquisition,
management systems and experience in development, and succession planning, with a focus on
implementing quality control measures to maintain fostering a learning and development culture to build a
product quality and adherence to specifications. skilled and engaged manufacturing workforce.
Problem-solving Skills: Effective problem-solving Innovation and Technology Adoption: Proactive
abilities to identify root causes of production issues, approach to identifying and implementing new
implement corrective actions, and drive continuous technologies, automation, and digital solutions to drive
improvement initiatives within the manufacturing efficiency, scalability, and competitiveness in the
process. manufacturing process.

Behavioral indicators for Quality Management include the following:

Continuous Improvement:
a. Looks for chances to upgrade systems and processes that affect quality.
b. Consistently examines quality indicators to pinpoint areas in need of improvement.
Problem-solving and Root Cause Analysis:
a. Uses a methodical, analytical approach to pinpoint the underlying causes of quality problems.
b. Takes preventative action to reduce the likelihood of quality problems.
Communication and Collaboration:
a. Effectively works with cross-functional teams to solve problems involving quality by setting right expectations
to the teams.
b. Actively contributes to high-quality meetings by offering analysis and constructive criticism.
Documentation and Record-keeping:
a. Follows proper document control procedures to manage revisions and updates. Maintains accurate and
detailed records of quality-related activities and processes.
b. Ensures documentation is complete, organized, and accessible as per regulatory requirements.
Assignment II
Identification of suitable BEI questions for each of the behavioural indicators
1. Continuous Improvement
It's crucial to concentrate on gathering precise and useful information about a person's
behaviours, actions, and experiences in order to gain insights into how individuals have
contributed to efforts to improve quality.
a. Could you give an instance where you proactively advised modifying a quality control
process? What effects did those adjustments have, and how did you go about making
them?
b. Describe a circumstance in which you came across a recurrent quality problem. What
steps did you take to address the underlying causes and stop it from happening again?
2. Problem-solving and Root Cause Analysis
It's crucial to concentrate on the candidate's capacity to recognise and methodically solve
quality-related issues.
a. Describe a circumstance where you came across a serious quality problem. Walk me
through the steps you took to determine the problem's underlying root cause.
b. Tell me about an instance when you investigated and fixed a quality issue using a
structured problem-solving process (like the 5 Whys or Fishbone Diagram). What
happened, and what did you take away from the encounter?
3. Communication and Collaboration
It's crucial to evaluate how candidates interact, engage, and work with others to achieve
quality-related goals.
a. Tell me about a time when you had to provide a teammate constructive criticism for
the calibre of their work. What tactics did you use to guarantee that the input was well-
received and resulted in improvement? How did you approach the conversation?
b. Give an instance where you actively solicited the opinions and advice of your team or
other colleagues to enhance quality processes or procedures. How did you promote
their involvement and incorporate their suggestions into the end result?
4. Documentation and Record-keeping
It's essential to focus on their attention to detail, organization, and ability to maintain accurate
and comprehensive records.
a. Tell me about a circumstance where you were needed to keep track of quality audits
or inspections. How were the documents managed and organised to facilitate access
and retrieval?
b. Can you give an instance where you have to ensure the security and confidentiality of
quality-related papers or records? How did you make sure that data privacy laws were
followed and stop unauthorised access?
c. Can you give an instance when you had to develop new standard operating procedures
(SOPs) or update existing ones for quality-related tasks? How did you make sure the
necessary stakeholders could understand and follow the procedures?
Assignment 3:
Create a competency map for one of the departments in your company

Department: Quality Management

Technical Regulatory Quality Problem Communication Continuous

Levels
Knowledge Compliance Management Solving & Collaboration Improvement
Director/Head
of Quality
Quality
Manager
Quality
Assurance
Specialist
Quality
Control
Analyst
Compliance
Coordinator
Document
Control
Specialist

Legend

Exceptional Advanced to Exceptional Proficient to Advanced Proficient Basic to Proficient Basic

Behaviourally Anchored Rating Scales (BARS)

Performance Role - Quality Assurance Specialist

Performance Dimension – Regulatory Compliance

1 - Unsatisfactory 2 - Developing 3 - Proficient 4 - Advanced 5 - Expert

•Displays a •Demonstrates a •Exhibits a thorough •To ensure compliance, •Serves as a recognised

misunderstanding of fundamental awareness of applies advanced compliance monitoring
regulatory obligations. awareness of regulatory standards. understanding of subject matter
•Failure to continuously regulatory standards. •Follows specified regulatory specialist.
follow established •Overlooks or misses compliance procedures requirements. •Creates and executes
compliance processes. compliance-related on a consistent basis. •Identifies potential comprehensive
•Non-conformities or processes on occasion. •Identifies and compliance concerns compliance plans.
compliance concerns •Requires periodic accurately reports and takes preventive •Provides compliance
are not identified or reminders to ensure nonconformities or measures. guidance and
reported. compliance criteria are compliance problems. •Conducts thorough mentoring to team
•Shows inadequate met. •Takes responsible for compliance audits and members.
understanding of the •Recognises the ensuring compliance inspections. •Acts as the
role's relevance of importance of standards are met. •Effective corrective organization's
compliance. compliance and the •Collaborates with team and preventative representative in
influence it has on members to handle actions (CAPAs) are regulatory interactions
quality. compliance issues. implemented. and audits.
 Assignment 4:
Create a career path for your unit, clearly mentioning the competencies required for the
various levels

Career Path for Manufacturing Business Unit

Well defined Career Paths provide fair opportunities for workplace advancement and compensation,
help address pay transparency laws and improve performance.

The manufacturing cluster offers the below career pathways:

1. Health, Safety, and Environmental (SHE) assurance;

2. Logistics and Inventory control;
3. Maintenance, Installation and Repair;
4. Manufacturing Production process development;
5. Quality assurance
Maintenance,
Health, Safety, and Logistics and
Sr No Level Installation Production Quality
Environmental (SHE) Inventory
and Repair
Director of Vice President of
Vice President of HSE Chief Quality Officer
Maintenance Manufacturing
Leadership Vice President of
1 Health, Safety, and Director of
Positions Operations
Environmental (HSE) Manufacturing Director of Quality
Director Process Development
Senior- Logistics Manager Quality Manager
Health and Safety Maintenance
2 level Inventory Control Production Manager Sr. Quality Assurance
Manager Supervisor
Positions Manager Specialist
Health and Safety Maintenance
Logistics Analyst Quality Engineer
Specialist/Coordinator Specialist
Mid-level
3 Process Engineer
Positions
Environmental Inventory Control Installation Quality Assurance
Specialist/Coordinator Supervisor Technician Specialist
Health and Safety Logistics Maintenance Quality Control
Entry-level Technician Coordinator Technician Inspector
4 Process Technician
Positions Environmental Inventory Control Repair Quality Assurance
Technician Specialist Technician Associate
Responsibilities and Competencies
Health, Safety, and Environmental (SHE) division

Health, Safety, and

Sr No Level Responsibilities Competencies
Environmental (SHE)
Extensive knowledge of
Establish company-wide HSE
stakeholder management,
rules, ensure compliance, and
strategic planning, policy
manage stakeholder
formulation, and HSE
relationships while providing
1. Health, Safety, and management, as well as good
the HSE team with strategic
Leadership Environmental (HSE) communication and
1 direction. oversee the HSE
Positions Director leadership abilities. broad HSE
function across the company,
2. Vice President of HSE knowledge, executive
establish the HSE vision and
leadership abilities, strategic
plan, and promote ongoing
thinking, engagement of
HSE performance
stakeholders, and capacity to
improvement.
influence cultural change.
Extensive familiarity with laws
governing health and safety,
Oversee risk management, proficiency in risk
design and implement policies management, understanding
and procedures, lead efforts of how to build policies,
for health and safety, and give aptitude for leadership, and
1. Health and Safety
the team direction. Lead good communication and
Senior-level Manager
2 environmental activities, strategic thinking skills.
Positions 2. Environmental
make ensuring regulations are comprehensive
Manager
followed, oversee understanding of
environmental reporting and environmental rules, program
programs, and give the team management competence,
direction. reporting and compliance,
leadership qualities, and the
capacity for strategic thought.
A thorough understanding of
Risk assessments, training,
health and safety laws,
development of health and
expertise in risk assessment,
safety plans, and assistance
program development, and
with incident management.
1. Health and Safety good leadership and
Environmental impact
Mid-level Specialist/Coordinator communication skills. strong
3 analyses, environmental
Positions 2. Environmental familiarity with environmental
program implementation,
Specialist/Coordinator regulations, aptitude for
environmental reporting
effect assessment, program
management, and ensuring
execution, data analysis, and
compliance with
coordination and
environmental standards.
communication skills.
Conduct inspections, assist in
monitoring and assuring
Basic understanding of
adherence to environmental
1. Health and Safety environmental, health, and
rules, and support
Entry-level Technician safety rules, meticulousness,
4 environmental programs, and
Positions 2. Environmental data analysis, problem-
the implementation of health
Technician solving, and effective
and safety policies, and
communication skills,
support incident
investigations.
Maintenance, Installation, and Repair division

Maintenance,
Sr No Level Responsibilities Competencies
Installation, and Repair
Oversee maintenance Skills in strategic planning,
operations, create rules and finance and budgeting,
procedures for maintenance, leadership, and the capacity
control maintenance budgets, to promote continuous
and guarantee that improvement in maintenance
1. Maintenance Manager requirements are followed. operations. Experience at the
Leadership
1 2. Director of Give the maintenance executive level, strategic
Positions
Maintenance department strategic thinking, decision-making
direction, ensure that talents, strong
maintenance goals are in line communication and
with business objectives, and leadership skills, and the
promote maintenance capacity to influence
excellence. organizational change.

Develop maintenance The ability to manage

schedules, manage maintenance teams, strong
maintenance budgets, and leadership abilities, and in-
give technical direction while depth knowledge of
supervising maintenance maintenance procedures.
Senior-level
2 Maintenance Supervisor tasks. extensive knowledge of
Positions
Manage repair operations, equipment repair, strategic
create repair plans, work with thinking, aptitude for
suppliers and vendors, and handling vendors, and the
streamline the repair capacity to oversee repair
procedure. crews.

Comprehensive
understanding of
Coordinate maintenance maintenance processes,
tasks, perform preventive highly developed technical
maintenance, and identify skills, capacity to solve
Mid-level 1. Maintenance Specialist complicated equipment problems, and ability to
3
Positions 2. Installation Technician problems. Install new manage small maintenance
equipment, upgrade existing teams. technical know-how,
equipment, and guarantee the capacity to understand
proper operation. technical drawings, and an
attention to detail when
installing equipment.
Performing standard Technical proficiency,
maintenance activities, attention to detail, problem-
resolving equipment solving skills, and a
1. Maintenance problems, and helping to willingness to learn are also
Entry-level
4 Technician install equipment. Perform required. basic knowledge of
Positions
2. Repair Technician equipment inspections, aid how to fix equipment,
with equipment maintenance, technical know-how,
and fix and diagnose problem-solving prowess, and
equipment issues. attention to detail.
Production division

Sr No Level Production Responsibilities Competencies

Provide strategic direction for

Executive-level experience,
manufacturing process
strategic planning skills,
development, align process
leadership abilities, financial
development goals with
acumen, and ability to drive
1. Director of company objectives, and
innovation and change.
Manufacturing Process drive continuous
Leadership Extensive executive-level
1 Development improvement initiatives.
Positions experience, strategic thinking,
2. Vice President of Oversee manufacturing
decision-making skills,
Manufacturing operations, including process
leadership abilities, and ability
development, production,
to drive operational
and quality, and provide
excellence and business
strategic leadership for the
growth.
manufacturing division.

Extensive experience in
Manage manufacturing manufacturing process
process development and development, process
improvement projects, ensure optimization expertise,
process stability and project management skills,
1. Manufacturing Process
reliability, and lead process and ability to lead and mentor
Senior-level Manager
2 validation activities. Identify a team. In-depth knowledge
Positions 2. Manufacturing
and implement new of manufacturing
Technology Manager
technologies, drive process technologies, innovation
innovation, and collaborate mindset, strategic thinking,
with internal and external stakeholder management
stakeholders. skills, and ability to drive
change.

In-depth knowledge of
manufacturing processes,
Design and optimize
process optimization skills,
manufacturing processes,
data analysis, problem-solving
develop process control
abilities, and strong
strategies, and collaborate
communication skills. Strong
Mid-level with cross-functional teams.
3 Process Engineer understanding of
Positions Lead process development
manufacturing process
projects, identify process
development, project
improvement opportunities,
management skills, analytical
and implement new
thinking, and ability to drive
technologies.
cross-functional
collaboration.
Assist in developing and
Basic understanding of
optimizing manufacturing
manufacturing processes,
processes, perform data
technical skills, data analysis
analysis, and support process
abilities, attention to detail,
improvement initiatives.
Entry-level and willingness to learn. Basic
4 Process Technician Conduct research and
Positions knowledge of research and
development activities,
development principles,
collaborate with cross-
technical skills, problem-
functional teams, and assist in
solving abilities, and ability to
process scale-up and
work in a team.
optimization.
Logistics and Inventory division

Sr No Level Logistics and Inventory Responsibilities Competencies

Oversee end-to-end supply

Executive-level experience,
chain operations, including
strategic thinking, financial
logistics, inventory control,
acumen, strong leadership
procurement, and demand
and communication skills, and
planning.Provide strategic
1. Supply Chain Manager the ability to drive
Leadership direction for the
1 2. Vice President of operational excellence.
Positions manufacturing division,
Operations Comprehensive knowledge of
oversee all operational
supply chain management,
functions, including logistics
strategic planning, supplier
and inventory control, and
relationship management,
drive continuous
strong leadership, and
improvement.
decision-making skills.
Extensive knowledge of
logistics management,
strategic planning skills,
negotiation abilities, strong
Oversee logistics operations,
leadership, and proficiency in
manage transportation
logistics software and
providers, optimize supply
1. Logistics Manager systems. Extensive
Senior-level chain efficiency, and ensure
2 2. Inventory Control understanding of inventory
Positions on-time delivery. Manage
Manager management principles,
inventory control processes,
experience in implementing
develop inventory strategies,
inventory control systems,
and optimize inventory levels.
strategic thinking, leadership
skills, and proficiency in using
inventory management
systems.
In-depth knowledge of
logistics principles, data
analysis and modeling skills,
Analyze transportation data,
problem-solving abilities, and
optimize shipping routes, and
proficiency in logistics
identify cost-saving
software and systems. Strong
1. Logistics Analyst opportunities. Supervise
Mid-level understanding of inventory
3 2. Inventory Control inventory control activities,
Positions management principles,
Supervisor coordinate stock
leadership skills, ability to
replenishment, and
develop and implement
implement inventory control
inventory control procedures,
strategies.
and proficiency in using
inventory management
systems.
Basic knowledge of logistics
and inventory control
Assist in coordinating principles, attention to detail,
transportation, managing organizational skills, and
shipments, and tracking proficiency in using logistics
1. Logistics Coordinator
Entry-level inventory. software and systems. Basic
4 2. Inventory Control
Positions Assist in managing inventory understanding of inventory
Specialist
levels, conducting stock control processes, data
counts, and ensuring accuracy analysis skills, attention to
of inventory records. detail, and proficiency in
using inventory management
systems.
Quality division

Sr No Level Quality Responsibilities Competencies

Oversee all aspects of quality

management across the
organization, set quality
Extensive executive-level
objectives, lead quality
experience, decision-making
improvement initiatives, and
abilities, strategic planning
drive quality excellence.
1. Vice President of skills, leadership abilities,
Leadership Provide executive leadership
1 Quality financial acumen, ability to
Positions for quality management, set
2. Chief Quality Officer drive quality performance and
the overall quality vision and
customer satisfaction and
strategy, oversee quality
ability to drive quality as a
performance throughout the
core business value..
organization, and drive a
culture of continuous
improvement.

Oversee quality control and Extensive experience in

assurance functions, develop quality management,
and implement quality leadership and decision-
strategies, lead quality making skills, ability to drive
improvement initiatives, and continuous improvement,
ensure compliance with regulatory expertise, and
1. Quality Manager
Senior-level regulatory requirements. strong communication
2 2. Quality Assurance
Positions Provide strategic direction for abilities. Executive-level
Director
quality assurance activities, experience, strategic thinking,
establish quality policies and leadership and
procedures, drive quality communication skills, ability
culture, and ensure to manage complex quality
compliance with industry programs, and drive
standards and regulations. organizational change.

Comprehensive
Develop and implement
understanding of quality
quality control plans, perform
assurance practices, auditing
root cause analysis, lead
skills, regulatory knowledge,
process improvement
ability to develop and
projects, and provide
implement quality systems,
1. Quality Engineer technical support to resolve
Mid-level and attention to detail. In-
3 2. Quality Assurance quality issues.
Positions depth knowledge of quality
Specialist Conduct internal audits,
engineering principles,
coordinate external audits,
statistical analysis skills,
manage corrective and
problem-solving abilities,
preventive action processes,
ability to lead cross-functional
and ensure compliance with
teams, and understanding of
regulatory standards.
quality management systems.
Basic knowledge of quality
Conduct inspections and tests
assurance principles, data
on raw materials, in-process
analysis skills, documentation
components, and finished
abilities, and understanding of
products to ensure
1. Quality Control regulatory requirements.
compliance with quality
Entry-level Inspector Basic understanding of quality
4 standards. Assist in quality
Positions 2. Quality Assurance control processes, attention
assurance activities, perform
Associate to detail, analytical skills,
data analysis, support audits
ability to interpret
and inspections, and
specifications and
participate in quality
procedures, and adherence to
improvement initiatives.
quality protocols.