QA Reviewer

Deputize for the Analytical Team Leader as required, including providing technical and problem-solving support to the team.
Maintain in-depth knowledge of Agilent HPLCs, Empower, Winsotax software and LIMS.
Carry out project work associated with implementing new specifications and analytical methods required by pharmacopeial or customer requirements.
Receive and log samples for testing, schedule testing activities and support laboratory release processes.
Monitor and verify laboratory equipment and complete associated documentation.
Perform instrument calibration and maintenance and complete associated records.
Review and approve calibration and maintenance documentation as required.
Support development of new methods and perform validation activities.
Review and approve laboratory testing data and reports for release testing of finished products and raw materials.
Review and approve laboratory investigations in a timely manner.
Troubleshoot and investigate out-of-specification results.
Participate in internal and external audits and support implementation of CAPA actions.
Comply with GLP, GMP and safety requirements at all times.
Maintain the laboratory in a clean and organised condition.
Provide monthly reports and quality metrics as required.
BSc, Masters degree, or equivalent relevant experience desirable.
Minimum 5 years of experience in a GLP/GMP analytical laboratory environment within the pharmaceutical or medical device industry preferred.
Strong technical knowledge with the ability to troubleshoot HPLC, dissolution and other standard analytical instrumentation.
Proficient in audit trail review and data integrity assessment within regulated laboratory systems.
Good computer literacy skills.
Willingness and availability to travel for business purposes when required.

Employment type
Full-time

Work arrangement
No