Lab Stability Supervisor at Adcock Ingram

Key Job Outputs:

• Ensuring compliance with national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP) within QC laboratory.
• Ensuring awareness of cGMP and cGLP among all personnel.
• Ensuring that all Standard Operating Procedures (SOP’s) are initiated, reviewed, approved and implemented as per the required process. (When assistance is required by Support Manager).
• Planning and allocation of stability work.
• Ensuring that all Stability Products are tested in compliance to registered analytical methods and able to review the documents when required.
• Assisting the Stability and Process validation Manager to ensure that there is a system for management and distribution of all GMP/GLP documents.
• To be able to communicate all the products Out of specification and relevant updates to the Stability Program Manager.
• Ensuring that all customer complaints and all the other testing required for analysis in the department are tested in accordance with the relevant SOP.
• Ensuring that all Deviations and Change controls and CAPAs raised are properly documented, investigated and closed according to SOP.
• Assisting and ensuring that Product Quality Reviews (PQR) documentation is being done for all products in accordance with SOP and the PQR schedule, review and sign the reports.
• Ensuring participation and compliance with Out of Specification and Anomaly investigations and procedures.
• Ensuring that all the other products received in the laboratory such as Intermediates, finished products and Raw materials are approved and Authorized when required.
• Ensuring that Stability products and all the other products such as Finished products, Process validation and Raw materials received in the laboratory meet QC Standards, and cGMP SAHPRA requirements.
• Reviewing and confirming the compliance of test results ensuring adherence to product release specifications.
• Assisting with ensuring that all specifications, test methods and other quality control procedures are available.
• Ensuring training of QC Laboratory personnel is conducted in accordance with relevant procedure for relevant teams.
• Ensure all analysts are trained and competed to perform their duties and able to conduct training when necessary.

Requirements

• BSc degree/Diploma in Analytical Chemistry.
• Minimum 5 years’ experience in the QC laboratory, preferably pharmaceutical industry
• Understanding of Quality Control, and Good Laboratory Practice guidelines and firm understanding of GLP requirement for generated data integrity
• Good understanding of QMS.
• Computer literacy, word, excel.
• Review of analytical data will be an advantage
• HPLC, UPLC, GC and AA experience required (minimum of the at least 3 of the 4 skills)
• Decisiveness and action orientation and strategic Thinking ability
• Supervisory skills and able to do problem Solving