Assistant Manager, QA & Compliance

Responsibilities:

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 SOPs and SOPs related to Mysore site.

To review the site policy and procedures 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 equipments, area, and systems.

Ensure 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 as per procedure

Ensure the maintenance of department and premises.

To manage Quality Critical Event and ensure that event is escalated to the concerned party according to concerned global policy. 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 equipments, 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.

Other responsibilities assigned by the management time to time.

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.