In charge of: Supervises the activities of a Quality Control Laboratory in testing, and approval or rejection of finished products.
Duties and Responsibilities:
1. Quality Management
• Ensures the implementation of testing instructions and Standard Operating Procedures relating to a Quality Control Laboratory and compliance with requirements of Good Manufacturing Practice (cGMP).
• Ensures that correct, reliable, and accurate results are reported and archived.
• Where deviations occur, ensure that they are fully documented and investigated, reported to Quality Assurance promptly, as well as suggesting corrective actions and preventive actions for the future.
• Manages improvement projects in the Laboratory to improve the laboratory quality, efficiency, and productivity.
• Manages the personnel in the Laboratory, overseeing the professional and personal welfare of the personnel.
• Responsible for training and qualification of the personnel in the Laboratory and ensures that the required initial and continuing training is carried out and adapted according to need. Approves qualifications of the Laboratory personnel.
• Ensures that the Laboratory is adequately maintained, clean, and equipped with functioning, calibrated, and qualified equipment and systems.
• Ensures the documentation about activities in the Laboratory is handled and archived according to the relevant approved procedures.
• Prepares and approves Standard Operating Procedures, Work Instructions, Operating Instructions, and relevant forms about the Laboratory.
• Approves equipment validation protocols and reports (IQ/OQ)
• Approves Out of Specification investigation reports
• Approves Certificate of Analysis (CoA) for products and other certificates as required.
• Responsible for testing materials and products for release or reject, according to approved Standard Operating Procedures and Test Methods
• Ensures that the performance of testing by analysts is supervised by the Team Leader, who also reviews the raw data for accuracy, approves or requests clarification of, and signs the test records before the transfer of the results for release.
• Manages laboratory inventory.
- Education: B.Sc. in chemistry
- Experience in the pharmaceutical Quality Control field
- Training in cGMP.
Please apply here: