Senior Executive QA Role at Amneal Pharmaceuticals, Apply Now!
Are you seeking a fulfilling and growth-oriented career in pharmaceutical quality assurance? An exciting opportunity awaits in Ahmedabad, Gujarat, where you can take on a pivotal role in maintaining the highest standards of quality and compliance. As a Senior Executive – QA, you will be responsible for document control, regulatory compliance, risk assessment, and quality management, ensuring that pharmaceutical products meet stringent industry standards.
Join a dynamic and innovative work environment where your contributions will directly impact the safety, efficacy, and compliance of pharmaceutical products. Take the next step in your career—apply today and become an integral part of a leading pharmaceutical company!
Role & Responsibilities For Senior Executive QA Role:
Document Control:
- Manage document handling, issuance, distribution, and retrieval.
- Verify key documents like Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), protocols, layouts, and specifications.
- Issue approved standard formats and logbooks to user departments.
- Maintain and archive issued standard formats and logbooks as Senior Executive.
Change Control & Risk Management:
- Handle proposed changes per the change control procedure.
- Assess risks and verify the implementation of action plans.
- Investigate deviations using root cause analysis tools and perform impact assessments.
- Implement Corrective and Preventive Actions (CAPA) and ensure effectiveness.
- Conduct trend analysis of deviations, change control, and complaints.
- Participate in risk assessments for equipment, systems, and processes as Senior Executive.
Quality Review & Regulatory Compliance:
- Review product labeling artwork and update packaging components.
- Oversee the destruction of outdated printed packaging materials after artwork revisions.
- Track action items, extensions, and document verification as Senior Executive.
- Scan and provide regulatory documents for submissions.
Master Documentation & Issuance:
- Maintain master documents like the Site Master File, Validation Master Plan, Quality Manual, SOPs, protocols, batch records, and specifications.
- Issue, archive, and retrieve validation/qualification reports, batch records, and specifications.
- Provide numbering for BMR, BPR, and batch numbers for exhibit and commercial batches as Senior Executive.
- Distribute product development documents, including Ma-ster Formula Records and Stability Protocols.
- Provide regulatory affairs with requested documents for submissions.
Preferred qualifications: B.Sc / M.Sc / B.Pharm / M.Pharm
Keywords: Senior Executive QA, Quality Assurance Job, Ahmedabad City, Gujarat, India
