Assistant Manager, QC Investigation
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 42d ago
Undisclosed10–12 yrsfulltimeSourced from
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About this role
Description:
The position is responsible for in-process and final product quality investigations in compliance with internal standards and global regulatory requirements. The role focuses on interpreting analytical and microbiological data for accuracy and precision against approved specifications.The role involves identifying recurring quality issues, investigating OOS, OOT, deviations, and trends, and preventing potential production and product quality risks. The role audits and monitors manufacturing outputs using validated methods, instruments, and predefined specifications to accept or reject materials and finished goods. The role ensures robust documentation, regulatory readiness, and continuous improvement, while supporting corrective and preventive actions to enhance overall quality performance.
Essential Functions:
- Perform detailed QC investigations for OOS, OOT, deviations, and atypical results
- Interpret and evaluate in-process, finished product, and stability data against specifications
- Review analytical data, audit trails, and laboratory documentation for data integrity
- Identify ongoing and potential quality issues and recommend preventive measures
- Execute root cause analysis and ensure timely CAPA implementation
- Audit and monitor QC outputs for compliance
- Support acceptance or rejection decisions for RM, PM, IP, and FG samples
- Ensure regulatory compliance with GMP, GLP, and pharmacopoeial requirements
- Trend quality data to detect systemic risks and process variability
- Support internal and external audits and inspections
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 10 years or more in 10 - 12 Years
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Product qualityauditsCAPARoot Cause AnalysisRegulatory ComplianceManufacturingcomplianceQC
About Amneal Pharmaceuticals

Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
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