About this role
This role involves monitoring in-process quality checks in the manufacturing area (API) to ensure compliance with cGMP, SOPs, and regulatory requirements. The role involves real-time verification of manufacturing activities, documentation review, and effective communication with production and QA teams
Key Responsibilities
Ensure adherence to cGMP and GDP practices during all in-process activities.
Perform line clearance checks before starting production and packaging operations.
Monitor and verify critical manufacturing and packaging parameters as per approved BMR/BPR.
Review and ensure compliance with SOPs, protocols, and regulatory guidelines.
Verify sampling, labeling, and dispensing of raw materials and intermediates.
Perform in-process checks and record observations in real-time.
Ensure timely identification, documentation, and escalation of any deviations, OOS, OOT, or incidents.
Support QA team in investigations and CAPA implementation.
Participate in internal audits, regulatory inspections, and compliance activities.
Maintain effective communication with Production, QC, and QA teams for smooth operations.
Ensure that all activities are performed safely and in accordance with company policies.
Skills & CompetenciesStrong knowledge of cGMP, GDP, and regulatory compliance.
Hands-on experience in API manufacturing processes.
Good understanding of QA/QC procedures.
Strong communication and interpersonal skills for cross-functional coordination.
Documentation accuracy and attention to detail.
Ability to work in a fast-paced manufacturing environment.
Other facts
About Amneal India
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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What you'll do
- The Trainee Officer, Quality Assurance will monitor in-process quality checks to ensure compliance with cGMP, SOPs, and regulatory requirements. Responsibilities include real-time verification of manufacturing activities and effective communication with production and QA teams.
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