Quality Engineer - Equipment and Commissioning
Newark Metro Area, NJ
- Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Execute the historical performance review (HPR), a bi annual review of equipment performance and use.
- Compile data gathered from HPR and use to analyze trends that could show equipment failure or out of trend.
- Review equipment logbooks, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
- Identify and recommend actions to take as a result of the completed HPR.
- Perform gap analysis on existing equipment and technologies to ensure compliance.
- Review new equipment and technologies as it comes to site to ensure compliance.