Quality Control Supervisor ( API )
Manpower Malta is seeking a Quality Control (QC) Supervisor to oversee the analysis and quality control of Active Pharmaceutical Ingredients (APIs), raw materials, intermediates, and finished products. The role involves managing laboratory operations, ensuring compliance with quality standards, and supporting analytical method validation.
Key Responsibilities:
Analytical Testing & Quality Control:
- Perform quantitative and qualitative analysis of APIs, raw materials, intermediates, and finished products.
- Conduct cleaning validation analysis.
- Oversee stability data management and ensure compliance with quality standards.
- Supervise the study and execution of analytical methods and method validation.
- Carry out sampling operations for raw materials, intermediates, and finished goods.
Laboratory & Equipment Management:
- Manage chemical-physical standards used in analysis.
- Perform internal periodic calibration of instruments as per procedures.
- Oversee retention sample management and storage conditions (e.g., silica gel control).
- Ensure the proper preparation and analysis of reagents.
- Supervise solid/liquid laboratory waste management and activation/deactivation of utilities.
Compliance & Documentation:
- Maintain and update department documentation and records of analytical results.
- Compile certificates of analysis and verify in-process control data sheets.
- Manage the list of qualified suppliers and supplier qualification processes.
- Issue and oversee the management of approved and rejected labels.
- Assign and manage codes for analytical methods, reagents, reference standards, and finished micronized products.
External & Supplier Coordination:
- Liaise with external laboratories for product analysis and release.
- Coordinate with analytical equipment suppliers to resolve technical issues.
General Responsibilities:
- Ensure a clean and organized laboratory environment.
- Record analytical results and maintain chromatographic data software.
- Supervise the retesting of warehouse materials and investigations of non-conforming results.
- Prepare and manage samples for consignment.
Qualifications & Skills:
- Bachelors or Masters degree in Chemistry, Pharmaceutical Sciences, or related field.
- Experience in quality control supervision within the pharmaceutical industry.
- Strong knowledge of analytical techniques and GMP/GLP compliance.
- Excellent attention to detail, problem-solving, and organizational skills.
Working Hours: Monday to Friday, 40 hours per week.
Shift Schedule:
- 06:00 - 14:00
- 14:00 - 22:00
- 08:30 - 17:00