JOB IDENTIFICATION:

Department: Production

Reporting to: Production Specialist

POSITION PURPOSE:

To oversee and coordinate production activities during assigned shifts to ensure compliance with GMP standards, productivity through Lean and Six Sigma methodologies. The Shift Leader is responsible for monitoring shift performance, supervising operators and technicians, and ensuring proper documentation and quality standards while fostering a culture of continuous improvement and accountability.

JOB ROLES AND EXPECTATIONS:

Key Result Area and Key Roles / Duties

Production Operations Supervision

• Coordinate daily manufacturing activities within assigned shift.
• Allocate duties and supervise production operators, technicians, and support staff.
• Monitor critical process parameters during BFS filling, dispensing, manufacturing, sterilization, and packaging.
• Ensure compliance with batch production records and SOPs during operations.
• Monitor equipment performance or deviations and escalate.

Compliance & CGMP Practices

• Ensure adherence to current Good Manufacturing Practices during production activities.
• Verify that all production documentation is correctly completed, reviewed, and signed by authorized personnel.
• Conduct line clearance and hygiene checks before batch start-up.
• Escalate non-conformities to the Production Specialist and Quality Assurance.
• Support waste reduction and yield optimization efforts.
• Apply Lean and Six Sigma practices to maintain work place efficiency.

Training

• Supervise, coach, and mentor shift team members to improve performance.
• Ensure discipline, punctuality, and teamwork among production staff.
• Assist in training new operators on SOPs and cGMP standards.
• Conduct briefings at the start and end of each shift.

Health Safety & Environment

• Promote a culture of safety and hygiene on the production floor.
• Ensure compliance with PPE usage and safety protocols.
• Report any safety incidents or near-misses immediately

Documentation & Reporting

• Review and ensure completeness of BMRs, cleaning logs, and shift handover notes.
• Record hourly output, downtimes, and deviations during the shift.
• Submit accurate shift reports and highlight critical issues or improvements

AUTHORITIES:

• Supervise all shift production personnel.
• Approve minor adjustments to equipment within validated limits.
• Halt operations if product quality, safety, or compliance is at risk.

COMPETENCIES:

Technical Knowledge/ Skills:

• Understanding of pharmaceutical manufacturing processes
• Strong knowledge of CGMP and regulatory requirements
• Equipment monitoring and troubleshooting skills
• Excellent documentation and record-keeping
• Good communication and interpersonal skills
• Basic computer skills (Excel, Word).

Behavioral / Attitude Competencies:

• Team Leadership
• Attention to detail
• Accountability
• Initiative and proactivity
• Conflict resolution
• Calm under pressure
• Shift flexibility
• Ethical and honest behavior.

MINIMUM QUALIFICATIONS / REQUIREMENTS:

• Bachelor’s degree or Diploma in Industrial/Mechanical/Production Engineering, pharmaceutical Sciences or related field.
•  3–5 years of experience in an FMCG manufacturing environment, with at least 1 year in a supervisory or lead role.
• Experience in a pharmaceutical /healthcare industry is an advantage.
• Strong understanding of GMP, safety, and quality systems.
• Knowledge of HACCP and ISO quality standards is essential.
• Proficiency in OEE tracking tools and Lean/Six Sigma methodologies.
• Willingness to work shifts including nights, weekends, or holidays.

TRAINING REQUIREMENTS:

• Basic safety training
• Shift leadership and Supervision
• Basic GMP training
• Equipment Operation and Hygiene