Head - Quality Assurance - Pharma (15-20 yrs)

Quality Assurance Head (Softgel Experience)

- To evolve, implement and monitor Quality Assurance activities at the facility.

- To define system, standards and procedures follow and to ensure the availabilityof authorized procedures / specifications.

- To undertake quality review of systems, products and furnish quality audit reportsto the management on annual basis

- To conduct internal audit programs (self-inspection) by creating an audit team of cross functional departments.

- To submit self-inspection report with recommendations for compliance to the management.

- To authorize MFRs, MPRs, Product Track Sheets, BMRs, and BPRs.

- Ensure compliance of national and International regulatory cGMP requirements.

- Approve and verify implementation of defined systems, standards and procedures for all key activities of the organization.

- Review and approve Batch Manufacturing and testing Records, before giving product release.

- Release of Product to the market.

- Review and Authorize Master Validation Plan, Protocols and provide support for validations.

- Ensure compliance of Change control and Deviation procedures.

-Ensure Induction and training of employees as per Training Policy procedure.

- Ensure the control over the Process including in-process checks/inspections/line clearances.

- Ensure the Inspection of final packed stock, before release.

- Investigate complaints, deviations, quality incidents and non-conformances.

- Handling of regulatory inspections at the site.

- To discuss the critical observation of self-audits with unit heads and imparting training to avoid critical deviations and improve the system by implementing reviewed actions to prevent any deviation in system, process or facility which would affect quality of the product.

- Take actions on Product recalls, investigate the reasons and report by co-coordinating with management.

- Ensure implementation of amendments in specifications and procedures as per current pharmacopoeia standards.

- Ensure implementation of Pest and rodent controls, as per defined schedules.

- Review and approval Product stability reports.

- Review and approval of Batch Manufacturing, Batch Packing Records, verify reconciliation of batch inputs, batch yields and finally release the product for sale.

- Responsible for Vendor Auditing and Evaluation.

- Review and approval of annual product quality review and APQR Schedules.

- To coordinate with Quality control in establishing the new Vendors periodically & also reviewing & updating the same to the purchase department/warehouses.

- Ensure cGMP / GLP and SOP training to the staff.

- Ensure proper storage, retrieval of records and destruction of obsolete Documents.

- Maintenance of control samples and its destruction.