Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company. Our development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines, team of 7,500+ colleagues helps make healthy possible through.
Post : Senior Executive, IPQA
Job Description
Essential Functions :
• Take regular plant rounds to monitor production and ensure compliance with standard operating procedures (SOPs) and GMP.
• Review Batch Manufacturing Records (BMRs), Batch Cleaning Records (BCRs), and analytical records prior to API release.
• Perform sampling of API, intermediates, and KSMs (Key Starting Materials), ensuring cleaning and maintenance of sampling tools.
• Provide line clearance at product changeover and critical process steps.
• Support documentation control activities, ensuring timely filing and retrieval of records.
• Maintain, monitor, and review controlled and retained sample records for intermediates, finished API, and KSMs.
• Ensure adherence to Good Documentation Practices (GDP) and data integrity principles.
• Escalate deviations or discrepancies observed during plant rounds or documentation review.
Additional Responsibilities :
• Support internal and external audits by providing necessary records and compliance data.
• Assist in preparation and review of SOPs related to IPQA activities.
• Participate in training activities to stay updated with quality and compliance standards.
• Coordinate with QA, QC, and production teams for timely resolution of quality issues.
Candidate Profile
Education :
Master Degree, M. Sc – Organic Chemistry - Preferred
Bachelor Degree, B. Pharma - Preferred
8 years of experience in IPQA activities in an API manufacturing unit
Skills
• Basic knowledge of GMP and cGMP compliance – Intermediate
• In-process Quality Assurance and Line Clearance – Intermediate
• Documentation Control & Review – Intermediate
• Data Integrity & Good Documentation Practices (GDP) – Intermediate
• Sampling Procedures and Sample Management – Intermediate
• Record Management and Compliance – Intermediate
• Team coordination and shop-floor presence – Basic.
Additional Information
Qualification : B.Pharm, M.Sc
Experience : 8 years
Location : Ahmedabad, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Job Identification : 6527
End Date : 20th October 2025
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