Manager Quality Assurance

Minimum Qualification: M. Pharma/ B. Pharma/M.Sc.

Candiate shall be well versed with manufacturing and packaging operations, Compression Machines, Isolators, Blenders, Bulk packing lines, & Process Validation.

Followings will be the responsibilities of the position holder:

To ensure compliance of current Good Manufacturing Practices in the Hormone facility & to follow GDP with data-integrity compliance.

Preparation, and review of qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.) for Hormone facility.

Preparation, review and approval of process validation and cleaning validation protocols for Hormone facility.

Management of control sample Preparation, updating, review and approval of Validation Master Plan, Site Master File, Quality Manual for Hormone facility. Co – ordination with other departments for streamlining qualification, validation, IPQA and QMS activities for Hormone facility. Handling of QMS activities (Change Control,  Exceptions, CAPA, Market complaints) for Hormone Facility. Batch release – Responsible for review of the executed batch documents and release of finished product for Hormone Facility.

To ensure effective working of In-process Quality Assurance activities including ensuring calibration of IPQA instruments as per schedule for Hormone Facility. Preparation and review of APQR.

To review and approve batch records of Hormone Facility. To conduct self-inspection/ internal audit as per site Internal Audit Program.

To investigate and provide CAPA for self-inspection/ internal audit and external audit observation. Co-ordination with Service providers for the qualification / validation activities. Qualification of service providers for Hormone Facility.  Review of Calibration and Preventive Maintenance related documents.