Asst. Manager QA and Regulatory
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
- 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
Office Location
Surat
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