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Amneal Pharmaceuticals
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Senior Executive, IPQA

Senior Executive, IPQA

Amneal Pharmaceuticals

3 - 6 years

5 - 8 Lacs

dahej

Posted:2 hours ago| Platform:

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Skills Required

manager quality assurance compliance ipqa analytical shop floor inprocess quality standard operating procedures data integrity gmp document control

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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

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Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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Senior Executive, IPQA