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Qc Support Manager Analytical Development, Stability

4 months ago

Johannesburg, South Africa PSM Personnel Full time

QC Support Manager - Analytical Development, Stability Laboratory ~ Manufacturing

Johannesburg North-Gauteng

Job Purpose:
Manage the Stability and Analytical Development section. Planning, executing of all Stability and Analytical process Development activities within the site/laboratory. Ensure GLP and SAHPRA requirements are adhered to with regards to all laboratory activities. Ensure that testing of Process Validation, Analytical Method Transfer and Stability samples are in accordance with the inhouse and regulatory requirements. Ensure testing of customer complaints are done timeously. Ensure compliance of procedures and facility with Total Quality Management, Good Manufacturing and Good Laboratory Practices. Making sure Stability and Process Development analysis are carried out in compliance with product license commitments, cGMP and company Quality Standards. Ensure testing of Stability and Process Development and Analytical Method Transfer is done timely. Reviewing and approvals of Process Validation and Analytical Method Transfer Protocols - Ensure all safety and quality events are investigated and with root causes determined ensuring CAPA' s are identified and executed.

You will need the following qualifications and experience:

- BSc or National Diploma in Chemistry or Equivalent
- 8 years' Laboratory experience in the pharmaceutical manufacturing industry
- QC Laboratory supervisory experience is required
- Good understanding of cGMP and pharmaceutical Laboratories is required
- Pharmaceutical drug/process development experience
- Knowledge of Analytical Method Validation and Transfer
- Knowledge of process validation and requirements
- Knowledge of handling customer complaints as per SAHPRA requirements
- Knowledge on SAHPRA requirement regarding Stability
- Knowledge of the SAHPRA requirements regarding customer complaints testing
- Computer literacy/MS Office
- Management experience will be advantageous
- Knowledge on equipment and instruments calibration.
- Monitoring of the calibration plan
- Making sure laboratory training and analysts qualification is done as per the plan.