Assistant Manager, QA City: Mysore **Your 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 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.