Job Description

Description:

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining 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 inspections, sampling, and testing of all incoming raw materials, packaging components, and returned goods in accordance with detailed written procedures. Prepare and deliver samples for chemical and microbiological (where required) analysis to the QC lab.
• Inspect and test packaging components using scales, micrometers, height gauges, and other devices to verify conformance to specifications. Maintain accurate records of all sampling, inspections, and testing activities.
• Assign and verify expiry dates and retest dates for GMP raw materials based on vendor and in-house Certificates of Analysis (COA). Collect packaged product samples for annual stability testing.
• Conduct room, equipment, and packaging line checks prior to each stage of manufacturing, following written procedures. Perform in-process testing per manufacturing and packaging batch record instructions.
• Prepare controlled, uncontrolled, and packaged finished product samples for QC lab testing and QA retains, ensuring full documentation. Maintain standard weights required for daily balance verification.
• Manage labeling components, including receipt, visual inspection, counting, preliminary testing, and sampling. Prepare inspection reports, quarantine and release labels, and maintain incoming component logs and inventory cards.
• Issue labeling components/outserts per packaging order and conduct regular monitoring and auditing of the label room. Complete QA final labeled product inspection reports and perform final line clearances, including labeling and packaging reconciliation.
• Ensure warehouse compliance with isolation standards for Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Properly isolate and account for rejected materials during batch processing.
• Monitor facility and product environmental operating conditions.
• Review engineering records, including temperature/humidity data, calibration/PM records, pest control logs, and contractor-related functions.
• Review online batch records for completeness of signatures, entries, reconciliation, and yields prior to initiation of subsequent processing steps.
• Verify equipment functionality and associated controls during batch runs.
• Maintain retention sample room by monitoring temperature/humidity, replacing chart records on schedule, reviewing logs, and ensuring proper 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 from time to time assign.