Officer, IPQA
Amneal Pharmaceuticals, Inc.
Description
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:
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To ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
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To supervision of dispensing activity of manufacturing shop floor and packing areas.
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To Issuance of Bottle label, Ouster and Medication guide for commercial batch.
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Rsponsible for providing machine and area clearance.
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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.
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Online Documents and records review like equipment's logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
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Calibration of IPQA instruments.
Additional Responsibilities:
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Real-time Monitoring and Compliance Reporting.
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Participation in Investigations.
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Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices.
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Maintain IPQA-related documents and records in a state of audit readiness.
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To have good written and verbal communication skills in English language.
Eligibility Criteria
- Experience: 2+ years
- Seniority: Entry Level
- Education: Bachelor's degree required
- Languages: English
About Amneal Pharmaceuticals, Inc.
Amneal Pharmaceuticals develops, manufactures, and markets generic and specialty medicines worldwide.