Job Summary

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

• All requirements from Inspector II, 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 reconciliation / 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 for chart records as per schedule, review of log and disposition of samples. plus the following :
• Monitor and release of Purified Water System
• Generates, proof read and issues "in-house" labels as in accordance with Process Study protocols and master batch records.
• performs rinse and swab sampling for microbial cleaning verification
• Handling complaint samples, visual inspection or retention / complaints samples, Batch record review for the receipt of complaint batches, collection of complaints / retention samples for analytical testing in case of complaint investigation
• Identification of gaps in the manufacturing and packaging equipment and assess the impact on the quality of product
• Coordination with manufacturing and engineering teams to resolve compliance issues in a timely manner

Additional Responsibilities

• Performs rinse and swab sampling for microbial cleaning verification
• Handling complaint samples, visual inspection or retention / complaints samples, Batch record review for the receipt of complaint batches, collection of complaints / retention samples for analytical testing in case of complaint investigation
• Identification of gaps in the manufacturing and packaging equipment and assess the impact on the quality of product
• Coordination with manufacturing and engineering teams to resolve compliance issues in a timely manner
• Other duties that management may from time to time assign.

Education

High School or GED - Required

Work Experience

3 or more years experience in QA or related field - Required

Skills and Abilities

• Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guidelines - Intermediate
• High energy level and organizational skills - Intermediate
• A certain degree of creativity and latitude is required - Intermediate
• Computer Skills ( Word and Excel) - Intermediate

Last updated : 2024-05-30