Amneal Pharmaceuticals Hiring: Senior Executive, IPQA for API Manufacturing Unit
Pharm'Up 
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a global pharmaceutical company dedicated to making healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 high-quality medicines, is seeking a qualified and experienced professional for the role of Senior Executive in In-Process Quality Assurance (IPQA) at its facility in Ahmedabad, Gujarat.
💼 Job Details
| Category | Information |
| Post Title | Senior Executive, IPQA |
| Location | Ahmedabad, Gujarat |
| Industry Type | Pharma/Healthcare/Clinical research |
| Experience | 8 years of relevant experience in IPQA activities within an API (Active Pharmaceutical Ingredient) manufacturing unit is mandatory. |
| Education | Preferred: Master of Science (M.Sc.) in Organic Chemistry or Bachelor of Pharmacy (B.Pharm.). |
| Job Identification | 6527 |
| Application Deadline | October 20, 2025 |
📝 Key Responsibilities (Essential Functions)
The Senior Executive, IPQA, will be the guardian of quality on the shop floor, ensuring all manufacturing processes adhere to stringent regulatory standards. Core responsibilities include:
- Shop-Floor Compliance: Conducting regular plant rounds to monitor production activities and ensure strict compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
- Documentation Review for API Release: Critically reviewing all essential manufacturing documentation, including Batch Manufacturing Records (BMRs), Batch Cleaning Records (BCRs), and analytical records, prior to the release of the final API.
- Material Sampling and Control: Performing accurate sampling of API, intermediates, and Key Starting Materials (KSMs), while ensuring meticulous cleaning and maintenance of all sampling tools.
- Process Assurance: Providing line clearance at critical junctures, such as product changeover and other crucial process steps, to prevent cross-contamination and errors.
- Record Management: Supporting documentation control activities, including the timely filing and retrieval of all quality and manufacturing records.
- Sample Monitoring: Maintaining, monitoring, and reviewing controlled and retained sample records for intermediates, finished API, and KSMs.
- Data Integrity: Ensuring absolute adherence to Good Documentation Practices (GDP) and all principles related to data integrity.
- Escalation: Promptly escalating any deviations or discrepancies observed during plant monitoring or documentation review to the appropriate management levels.
➕ Additional Responsibilities
The role also involves supporting the broader Quality function:
- Audits Support: Providing necessary documentation and compliance data to support both internal and external quality audits.
- SOP Management: Assisting in the preparation and review of new or revised SOPs related to IPQA activities.
- Training & Coordination: Participating in necessary training activities to stay current with quality and compliance standards, and coordinating closely with the QA, QC, and Production teams for swift resolution of quality-related issues.
🛠️ Required Skills
Candidates must possess an Intermediate level of proficiency in the following technical areas:
- Basic knowledge of GMP and cGMP compliance.
- In-process Quality Assurance and Line Clearance procedures.
- Documentation Control & Review.
- Data Integrity & Good Documentation Practices (GDP).
- Sampling Procedures and Sample Management.
- Record Management and Compliance.
A Basic level of proficiency in Team coordination and shop-floor presence is also required.
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