"Alerted.org

Description:

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 all functions of a QA Inspector I.

+ Inspect, sample, and test all incoming raw materials, packaging components, and returned goods according to detailed written procedures.

+ Prepare samples for chemical and microbiological analysis (where applicable) and deliver them to the QC lab.

+ Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges to ensure conformance to specifications.

+ Maintain detailed records of all sampling, inspection, and testing activities.

+ Assign and verify expiry and retest dates for GMP raw materials using vendor and in-house Certificates of Analysis (COAs).

+ Collect packaged product samples for annual stability studies.

+ Perform room, equipment, and packaging line checks prior to each manufacturing stage, following written procedures.

+ Conduct in-process testing as per manufacturing and packaging batch record instructions.

+ Prepare finished product samples (controlled/uncontrolled/packaged) for QC lab testing and QA retains, ensuring proper documentation.

+ Maintain standard weights for daily balance verification.

+ Receive, visually examine, count, preliminarily inspect, and sample labeling components.

+ Prepare inspection reports for labeling components/outserts; quarantine and release labels; maintain incoming component logs and inventory cards.

+ Issue labeling components/outserts per packaging orders and regularly monitor and audit the label room.

+ Complete QA final labeled product inspection reports and final line clearance, including labeling and packaging reconciliation paperwork.

+ Ensure warehouse compliance regarding isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.

+ Properly isolate rejected materials generated during batch processing and ensure accountability in batch records.

+ Monitor facility and product environmental operating conditions.

+ Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)

+ Review of online batch records in terms of completeness of signatures, entries, and actual reconcilaiton / yields prior to initiation of next processing step

+ Verification of functionality of all the equipment and associated controls during the batch run

+ Maintenance of retention sample room and monitoring of temperature and humidity, replacement fo chart records as per schedule, review of log 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 from time to time assign.