About this role
This role is responsible for monitoring and ensuring that all incoming raw materials, packaging components, and returned goods are properly sampled, inspected, and tested, as applicable, to confirm compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run.
Essential Functions:
- Perform inspection, sampling, and testing (where applicable) on all incoming raw materials, packaging components, and returned goods following detailed written procedures.
- Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab.
- Inspect and test packaging components using various measuring devices such as scales, micrometers, and height gauges to determine conformance to specifications.
- Maintain detailed records of sampling, inspections, and testing activities.
- Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and in-house COA.
- Collect packaged product samples for annual stability.
- Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures.
- Conduct in-process testing per manufacturing and packaging batch record instructions.
- Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains, following detailed documentation procedures.
- Maintain standard weights required to perform daily verification of balances.
- Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
- Prepare labeling components/outserts inspection reports; quarantine and release labels; maintain incoming components log and corresponding inventory cards.
- Issue labeling components/outserts according to packaging order and regularly monitor and audit the label room.
- Complete QA final labeled product inspection report and final line clearance, including labeling and packaging reconciliation paperwork.
- Ensure compliance of warehouse areas in terms of isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
- Ensure proper isolation of rejected material generated during batch process and accountability in the batch record.
- Monitor facility and product environmental operating conditions.
- Review engineering records (temperature and humidity data, calibration and PM records, pest control records, and contractor-related functions).
- Review online batch records for completeness of signatures, entries, and reconciliation/yields prior to initiation of the next processing step.
- Verify functionality of all equipment and associated controls during the batch run.
- Maintain retention sample room and monitor temperature and humidity; replace chart records as per schedule; review logs and disposition of samples.
Additional Responsibilities:
- Disposition of rejected material and returned drug products as per SOP
- Performs environmental monitoring in accordance with established schedule (where applicable)
- Perform applicable testing and prepare report for customer complaints
- Other duties that management may assign.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
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.
Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.
Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.
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 Quality Assurance Inspector II is responsible for monitoring and ensuring compliance of raw materials and packaging components throughout the manufacturing process. This includes performing inspections, sampling, testing, and maintaining detailed records to ensure quality standards are met.
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