01
Oct
2018

CAPA Consultant

Metro Manila – CAPA Consultant NNIT Philippines Inc Keywords / expertise : CAPA, GxP, CSV, LIMS, Trackwise, SumTotal 2 – 10 years Published: 2018-09-26 APPLY Nationality Industry Function function Education Posted On 26th Sep 2018 Job Description Listing description This person will be responsible for » Ensured that the procedures and documentation adhere to 21 CFR Part 11, Annex 11, GMP, GAMP, and GDP. » Preparing validation strategies, planning, execution, documentation, and review and approval of the qualification of laboratory equipment & software, that can include FTIRs, HPLCs, GCs, PXRD, LIMS, ELN, and Empower 3. » Formally track and document CAPA’s, project change records, task status, project timelines, and discrepancies. » Review and approve installation, functional, and performance located test plans and test cases (IQ, OQ, PQ). » Recommend process, documentation, and periodic review enhancements, assessed and improved activities and procedures related to softwar…

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