About this role
Description:
To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitoring, documentation review, sampling, and area/machine clearances, thereby supporting the production of high-quality injectable pharmaceutical products
Essential Functions:
- To ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
- To supervision of dispensing activity of manufacturing shop floor and packing areas.
- Responsible for providing machine and area clearance.
- To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol.
- Online Documents and records review like equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
- Calibration of IPQA instruments.
- Review of and release of Batch.
- Responsible to review the in-process and finished product COA before batch release.
- To perform aseptic behaviour/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.
Additional Responsibilities:
- Real-time Monitoring and Compliance Reporting.
- Participation in Investigations.
- Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.
- Maintain IPQA-related documents and records in a state of audit readiness.
- To have good written and verbal communication skills in English language.
Skills:
- In-Process Quality Control (IPQC) - Mastery
- Compliance and Regulatory Knowledge - Advanced
- Aseptic Process Monitoring & Compliance - Advanced
- Line Clearance & Batch Record Review - Intermediate
- Deviation, Investigation & CAPA Management - Advanced
- In-Process Checks & Monitoring - Mastery
- Deviation & Change Control Management - Advanced
- Equipment & Facility knowledge - Advanced
- Investigation Skills for Root Cause Analysis - Advanced
- Analytical Quality Assurance - Advanced
Other facts
About Amneal
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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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The role involves ensuring compliance with cGMP and regulatory requirements through in-process quality assurance activities on the manufacturing and packaging shop floor. This includes real-time monitoring, documentation review, sampling, and area/machine clearances.
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