Quality Assurance Job at Amneal | Executive – QA Validation Role
Looking for a Pharma QA Job in the pharmaceutical industry? Amneal Careers is hiring for the position of Executive – QA Validation in Ahmedabad. Candidates with B Pharm or M Pharm qualifications and experience in validation, GMP compliance, quality documentation, and risk management can apply for this opportunity.
- Job Role: Executive – QA Validation
- Department: Quality Assurance
- Location: Ahmedabad, Gujarat
About The Company
Amneal Pharmaceuticals is a global pharmaceutical company engaged in the development, manufacturing, and distribution of high-quality medicines. With a strong focus on innovation, regulatory compliance, and advanced manufacturing practices, Amneal provides excellent opportunities for professionals seeking growth through Amneal Careers in quality assurance and pharmaceutical operations.
Job Description
The selected candidate for this Pharma QA Job will be responsible for qualification, validation, documentation control, risk assessment, and GMP compliance activities. The role involves coordinating with cross-functional teams to ensure regulatory compliance, maintain quality standards, and support Amneal Careers initiatives in pharmaceutical quality assurance.
Key Responsibilities
- Prepare and review DQ, IQ, OQ, PQ qualification protocols and reports for equipment, utilities, and systems.
- Coordinate qualification activities with Engineering, Production, and Validation teams.
- Ensure compliance with GMP and regulatory requirements and manage requalification schedules.
- Perform quality risk assessments using FMEA, HACCP, and risk matrices.
- Develop and maintain SOPs, work instructions, protocols, and quality documents.
- Ensure proper document control and record management throughout the document lifecycle.
- Provide training on revised SOPs and maintain training records.
- Support process improvement initiatives, quality metrics, and trend analysis.
- Develop and review process validation protocols, reports, and Validation Master Plans (VMP).
- Coordinate process validation, cleaning validation, analytical method validation, and computerized system validation activities.
- Evaluate validation data and ensure processes meet predefined acceptance criteria.
Eligibility Criteria
- Education: B Pharm – Required, M Pharm – Preferred
- Experience: 2–5 years of experience in Quality Assurance and validation activities.
Required Skills
- Knowledge of GAMP 5 and 21 CFR Part 11.
- Strong understanding of ALCOA+ principles.
- Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
- Hands-on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
- Strong project management skills.
Why Join Amneal?
This Pharma QA Job at Amneal Careers provides an opportunity to work in a regulated pharmaceutical environment and gain expertise in validation, quality systems, GMP compliance, and regulatory requirements while building a strong career in Quality Assurance.
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