Key responsibilities :

- Planning and scheduling of all the works at Quality Assurance.

- Handling of customer audits, regulatory audits and CAPA related to the audits.

- Review and evaluation of QA (cGMP) reports and compliance.

- Reviewing of QA related documents and approval.

- Review and verification of Validation Master Plan.

- Review and approval of QA related validation protocol and reports.

- Handling of Nonconforming products.

- Handling of Batch Failure Investigation and CAPA.

- Handling of rejected / recalled materials.

- Handling of returned recalled product, OOS, OOT etc.

- Reviewing documents [Procedures (SOP, IOP, EOP, GAM, and Specifications etc.), validation protocol and reports, Batch records, checklists, qualification documents etc.] of other departments.

- Approval of Quality management system documents including SOPs, specifications and other documents.

- Handling of returned recalled product, OOS, OOT etc.

- Recruitment of QA personnel.

- Review and approval of annual product review.

- Vendor qualifications, audits and evaluation.

- Review and Handling of Quality Agreement (as applicable).

- EHS core committee member and implementation of procedures in quality department.

- Member of Post Vigilance Group for monitoring and handling of complaints.

Other responsibilities :

- To monitor flow of materials and product as per the written procedures.

- Document issue and control.

- Review of Batch Manufacturing Records, Batch Packing Records and Dispatch Records.

- Batch approval and Batch release.

- Control of QA related official seals.

- Approval of Standard Operating Procedures, Specifications, General Analytical Method, Instrument and Equipment Operating Procedures.

- Execution of validation activities (wherever applicable).

- Monitoring of Reprocessing and repacking activities (wherever applicable).

- Review and closure of Change Controls, Deviations and Complaints (customer and regulatory).

- Handling of Training at Quality Assurance.

- Review and Approval of trends (Environment, Water etc.).

- Review and approval of calibration and stability data.

- Approval of Quality management system documents including SOPs, specifications and other documents.

- Handling of internal audits.

- Recruitment of QA personnel.

- Approval of certificate of analysis (COA).

- All other activities designated by department head.

Desired Profile :

- Ideal Candidates should be Masters in Life-sciences with minimum 15 years of experience in handling QA of parenteral.

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