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  • QA Operations Consultant

    • ID:893738
    • Location:Germany -
    • Category:QA Compliance
    • Positions Available:1


    Our Client, an expanding biopharma CDMO based in Germany, currently requires the support of an experienced QA Operations Consultant to provide QA oversight on the shop floor as a result of a number of schedule changes. This role will not be 100% on the production floor but will also require some office based work as well.

    This role requires some is shift work – Day shift or second shift and maybe a sat or sun on rotation. . Candidates should be flexible to work either a day shift or 2nd shift (e.g. 3pm-11pm) or 12 hour shift on Saturday and/or Sunday.

    • Triaging deviation events and batch record reviews
    • Provide QA Oversight on the production floor during critical activities
    • Dealing with deviations on trackwise
    • Performing AQL – manual inspections
    • Gowning into Grade C and D areas surrounding an isolator. General activities to be observed include formulation, filling vials along the conveyor belt and manual visual inspection/AQL sampling

    • Sterile Manufacturing experience
    • Experience in either Drug Product or Drug Substance facilities
    • Must have an understanding of the manufacturing process, from formulation to fill
    • Must understand sterility
    • Good GDP experience
    • Enviromental monitoring experience would be good but not essential
    • Clean room experience
    • Fluency in German would be a distinct advantage

    • Start date: 1st week July
    • Contract Term: 6 months with potential to extend