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Lab Stability Supervisor

Adcock IngramZA

15 days ago

Job description

Job title : Lab Stability Supervisor

Job Location : Western Cape,

Deadline : October 13, 2025

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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

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