Ensure compliance to national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP) within the QC Laboratory.
Ensure that all raw materials or packaging materials meet QC Standards, and cGMP requirements.
Supervise the QC Packaging and sampling team in terms of training, work allocation, document approval and compliance to current SOP and procedures for the Laboratory.
Ensure all Standard Operating Procedures are initiated and reviewed as per the required process
Ensure that raw materials or packaging materials are sampled as per SOPs and tested in compliance to registered analytical methods and specifications
Ensure that all Deviations raised are properly documented, investigated and closed according to S.O.P
Ensure participation and compliance to OOS investigations and procedures
Reviewing and confirming the compliance of test results ensuring adherence to release specifications
Ensure that the approval or rejection process of raw materials and packaging materials are handled in accordance with the required procedure
Qualifications and Experience:
BSc Degree/Diploma in Analytical Chemistry or equivalent
4 or more years’ Pharmaceutical QC Laboratory experience
Supervisory and packaging materials experience will be an advantage
Understanding of Quality Control, Good Laboratory Practice guidelines and firm understanding of GLP requirements for generated data integrity
Computer literacy – Microsoft Word, Excel, Outlook and PowerPoint