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