- Ensure the proper upkeep of equipment and systems in the QC IPC/DS laboratory to maintain full compliance with cGMP standards as part of the shift team.
- Conduct product testing and analysis in accordance with cGMP guidelines to meet specified deadlines.
- Offer technical assistance in running and validating necessary testing methods on laboratory equipment and in the development of method transfer/validation protocols and reports.
- Conduct routine analytical testing for in-process, release, stability test, and validation samples, including but not limited to HPLC, UV, TOC, pH, and more.
- Effectively manage work priorities to ensure timely document review and testing.
- Create and review QC documents, encompassing assays of varying complexity, to guarantee their completeness, accuracy, consistency, and clarity, ensuring that materials or final products align with specifications and cGMP standards.
- Prepare for and participate in inspections by health authorities and internal audits within the respective area.
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