Teams at Endo

Perform microbiological testing of raw materials, in-process, finished, stability, swab and water samples; conduct environmental monitoring; perform instrument calibration, media/culture handling, method transfers/validation; maintain auditable records and GLP/GDP compliance; initiate change requests; complete trainings and uphold 5S and safety practices.

Perform routine and stability analytical testing of drug products and raw materials using HPLC, GC, UV, and dissolution. Maintain and troubleshoot instruments, ensure cGMP/GLP and FDA data integrity compliance, investigate OOS/OOT, support CAPA and audits, and participate in method transfer, verification, and validation while preparing analytical reports and SOPs.

Plan and execute shopfloor in-process quality assurance (IPQA) activities, authorize line clearances, perform in-process inspections and sampling, manage reserve and stability samples, calibrate IPQC instruments, review batch records, post QA transactions in SAP, conduct maintenance impact assessments, and ensure cGMP and EMS compliance.