Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.
Post : Executive, QA Validation
Job Description
• Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable).
• Coordinate and monitor qualification activities with Engineering, Production, and Validation teams.
• Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.
• Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices.
• Identify potential quality risks and recommend appropriate mitigation strategies.
• Ensure risk management documentation is maintained and periodically reviewed.
• Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents.
• Ensure document control procedures are followed throughout the document lifecycle.
• Coordinate periodic review of controlled documents.
• Provide training on new or revised SOPs and maintain training records.
• Identify opportunities for process improvement and quality enhancement.
• Support implementation of quality metrics and trend analysis.
• Participate in cross-functional quality improvement projects.
• Develop and review process validation protocols, reports, and validation master plans.
• Coordinate execution of process validation activities with cross-functional teams.
• Evaluate validation data and ensure processes consistently meet predefined acceptance criteria.
• Support cleaning validation, analytical method validation, and computerized system validation where applicable.
Additional 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
Required Skills
Data Integrity & Documentation Security
Documentation & Record Control
Equipment Qualification Oversight
Process Validation Master Plan
Quality Risk Analysis & Control
Regulatory Compliance
Regulatory Label Compliance Review
Validation & Qualification Oversight
Validation Protocol Implementation
Validation Reporting
Additional Information
Experience : 2 - 5 Years
Qualification : B.Pharm, M.Pharm
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
End Date : 30th September 2026
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