Titan Biotech - Senior Manager - Quality Assurance

- Responsible for leading the external audit & providing the compliance in timely manner.

- To ensure GMP/FSMS/HACCP Compliance in the plant.

- To review and approve all departments Standard operating Procedure.

- To ensure for the compliance of all Standard Operating Procedure.

- Strategic Planning & execution of Quality Management System.

- To ensure the compliance of Quality Management system as per the requirement.

- To review and approve the Site Manager File (SMF), Validation Master Plan(VMP) and Quality manual.

- Responsible for the approval and release of the Batch.

- To review & approve specifications, Standard Test Procedure (STP) and General Test Procedure (GTP) of Quality Control Department.

- Responsible for Self Inspection or Internal Audit and its compliance.

- To review and approve all Validation and Qualification Protocols and Reports.

- To ensure the compliance of Vendor Audits and approval of Contract Laboratory.

- To impart training on different topics including cGMP and GDP etc.

- To coordinate during technology transfer of products to the sites.

- To ensure that products are manufactured as per approved procedure.

- Responsible for the investigation of the market complaints, Product recall & its compliances.

- Responsible for review, approval and implementation and verification of Corrective Action and Preventive Action.

- To provide the compliance reports of audits.

- To ensure the Qualification and Re-qualification of the Equipment, Facility and System

- Responsible for review and approval of Stability Protocol and report.

- To ensure work discipline in the department.

- Responsible for quality agreement and its compliance.

- To review and approve all apex documents.

Minimum Qualification : M.S / M.Sc. in any specialisation or M. Pharma

Key Competencies :

- Should have prior experience of leading client and regulatory audits.

- Should have prior experience in bulk production of food/ pharma ingredients.

- Should possess excellent communication skills