Job Description:

Min experience of 6-8 years in Quality assurance and regulatory. Graduate or Post Graduate.

Requirements

- Graduate and/or 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 IVD/medical devices / injectable in Executive / Managerial position.
- Innovative thinking for solutions of problems arising out of established Quality Management System, Leader
- Valuable 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

Office Location

Surat

About

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