Job highlights

- . Graduate andor Post Graduate (Pharmacy,Biochemistry,Biotechnology,Chemistry.)

- Coordinate Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive actions (CAPA)

- Min experience of 6-8 years in Quality assurance and regulatory with preferably IVDmedical devices injectable in Executive Managerial position.

- Valuable written and spoken English

Asst.

Manager QA and Regulatory : Requirements

- Graduate andor Post Graduate (Pharmacy, Biochemistry, Biotechnology, Chemistry.)

- Knowledge of techniques involving quality assurance of pharmaceuticals antibodies Proteins

- On-job knowledge of in vitro MDD IVD documentation

- Min experience of 6-8 years in Quality assurance and regulatory with preferably IVDmedical devices injectable in Executive Managerial position.

- Innovative thinking for solutions of problems arising out of established Quality Management System,



Leader

- Good written and spoken English

- Computer proficiency (MS Excel, PPT, Word)

- Duties and Responsibilities
- Monitor Implemented Quality Control Systems

- Provide training wherever required
- To conduct Internal audits at regular intervals

- Coordinate Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive actions (CAPA).

- Qualification and Validations (Revalidation) of facility, equipment and processes

- Participate in the Vendor development and audits for raw materials and packing materials

- Support Quality Head in QMS and its effective implementation.

- Support in maintain effectiveness of established strategic vision for the Quality Assurance

📌 Asst. Manager QA and Regulatory (Surat)
🏢 Arkray Healthcare
📍 Surat