Asst. Manager QA and Regulatory

Asst. Manager QA and Regulatory Job Description: 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