- Supervise production activities to ensure processes are performing flawlessly according to SOPs.
- Complete batch documentation accurately and thoroughly while adhering to quality and safety standards.
- Assist the Production Manager in daily production activities and approve production cycles.
- Ensure all operators have completed relevant training before driving any task, closely following protocols.
- Review, approve, and track personnel-related data and documentation such as absence records and daily attendance.
- Manage inventory of packaging materials and supplies to prevent shortages.
- Allocate personnel and equipment optimally and liaise with associated departments for day-to-day issues.
- Report and assist in investigating quality deviations and troubleshoot related issues.
- Supervise a team, assign tasks, and provide necessary training.
- Build and review SOPs/WIs.
- Ensure adherence to cGMP and GDP.
- Coordinate preventive and breakdown maintenance, offering operational oversight of CM/PM/Calibration activities.
- Lead Continuous Improvement activities to improve quality and efficiency.
- If required, perform formulation, filling, and visual inspection activities as per SOPs and Batch Records.
- Perform SAP transactions at each manufacturing process step.
- Follow aseptic techniques and practices strictly in aseptic operations.
- Carry out cleaning and upkeep of production equipment and areas as needed.
- Prepare filters for testing and perform FIT (Filter Integrity Testing) as required.
- Communicate any anomalies observed in a timely manner.
- Participate in EHS, Business Compliance, cGMP, and other compliance-related matters.
- Perform tasks according to SOPs and maintain strict GMP compliance at all times.
- Conduct chemical and mathematical calculations to determine product potency and endotoxin levels as needed.
- Perform any other duties as assigned by the Manager.
Education
- Minimum NITEC/ITE education/Diploma in a relevant field.
Experience
- Minimum 5 years of confirmed experience in the pharmaceutical industry.
- 3 years of team lead experience.
Knowledge, Skills, Abilities
- Good understanding of safe working practices and cGMP.
- Highly motivated to work in the pharmaceutical industry.
- Able to work as part of a team.
- Able to work rotating shifts.
