AGM- Quality Assurance

Job Description

Job Title: Assistant General Manager Department: Quality Assurance Location: Ambernath Years of Experience: 16 + Years Dosage Form: Solid Oral/ Nasal Job Responsibilities: To ensure cGMP Compliance as per laid down procedures. Execute and Monitor key QA activities - Process validation, Cleaning Validation, Equipment Qualification, Instrument Qualification, Utility Qualification and Master Document review. Preparation and review of SOPs applicable to QA. Evaluation of QMS documents. Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports Participate in investigations and review of investigations. Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission Monitoring of document control, storage, and archival. To provide training to QA team members and other functions. Participate in customer and regulatory inspections and ensuring CAPA effectiveness. Participate in self-inspections. To audit the internal quality system as a part of self-inspection (internal audit). Timely and proactively escalating issues. Qualifications & Pre-Requisites Must-Have Skills: B. Pharm/ M. Pharm With relevant experience in pharma quality assurance. Must have knowledge of Process Validation, Cleaning Validation, Equipment Qualification and ability to handle the team. Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA. Exposure to specific dosage forms like OSD and Nasal. Must have shop floor experience and in-process quality assurance. Effective communication, Team coordination and work in collaboration within compliance Show more Show less