- To monitor the site quality system compliance requirement of Schedule M, MHRA, SAHPRA, ISO 9001 and other regulatory authorities.
- To Monitor planning and conduct of Self Inspection. Initiate and approve the corrective action plans. Compliance follow-ups for external audits.
- Investigate, review Deviations, Quality incidents and ensure adequate CAPA plans, its implementation and close-out in Quality One software.
- Ensure change controls are initiated, reviewed, & documented in Quality One software.
- Investigate, review consumer complaints & ensure appropriate CAPA implementation.
- Monitor the annual supplier audit schedule, Assessments and conduct audits for raw material and packing material suppliers as per schedule.
- Lead and manage the local Quality Assurance team.
- Ensure that finished products released as per the release procedure
- Review and approval of Supplier based on document assessment and audit outcome
- Prepare audit compliance reports and ensure CAPA in co-ordination with suppliers
- Monitor the Out of Specification & Out of trend results investigations
- Review audit trails for laboratory instruments.
- Review and approval of batch records and release of FG.
- Review, approve the Quality assurance SOP’s
- To review the site policy and procedure’s like VMP, SMF, PVMP, Protocols, specifications, test methods, batch documents & other site documents.
- Trend analysis of quality management system key performance indicators.
- To ensure that appropriate qualification, requalification and validations are done for site equipment, area, and systems.
- To control, maintenance, and issue of documentation for manufacture, compliant with the marketing and manufacturing authorizations requirements (regulatory bodies) and effective/efficient delivery of operational activities.
- To ensure the management review and annual product review program are maintained according to concerned GMP and QMS requirement.
- Ensure store checks are performed timely.
- To manage Quality Critical Event. To contribute as a member of quality critical event for reviewing of decision for the event such as continuing production and sales and level of recall etc.
- To ensure and monitor key quality process during NPD/EPD roll out from site.
- Ensure appropriate qualification and validations for site equipment’s, area and systems
- Ensure required initial and continuing training of department personnel & adapted according to need. Provide GMP trainings.
- To support all key initiative at the site as key member of the Site leadership team.
- Site Management review meetings & ensure completion of follow up actions.
- Motivate and drive the Quality team to continually improve the Quality Culture at site.
- To perform, review of the site risk register and evaluation.
- Ensure the monitoring and control of the manufacturing environment, plant hygiene, process validation, training.
- To understand all environmental & safety standard requirements and provide guidance to team.