Senior Qualified Person - EU/UK GMP & Batch Release
Replimune
Replimune Group, Inc., based in Woburn, MA, is seeking a Qualified Person (QP) to certify batches for EU/UK markets, ensuring GMP compliance and alignment with marketing authorisations. The role emphasizes heavy involvement in the full supply chain, batch records, and regulatory documentation. The successful candidate will have a scientific degree and at least two years in pharmaceutical manufacturing, sterile products experience, and knowledge of EU/UK GMP guidelines, with ATMP experience #J-18808-Ljbffr Replimune
$188k - $230k
...Facebook.Role Summary:The Director of QA GMP Operations is responsible for management... ...principles and ICH guidelines. Review batch records, analytical method reports and technical... ...of GMP batches and interfacing with the Qualified Person (QP). Change management to ensure proper...QualifiedLocal area- ...supply network supporting EU and international... ...hands-on oversight of batch record review, lot disposition... ...Viridian’s contracted Qualified Person (QP).This role is fully... ...readiness, and ongoing GMP readiness across EU and... ...knowledge of EU and UK GMP and GDP requirements...QualifiedWork at officeLocal areaImmediate startRemote work
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...Butcher Apprentice Program, or an equivalent training program.* UK Exceptions may apply Physical Requirements/Working Conditions... ...must exist and the candidate must be considered the most qualified person for the new position. Completion of certain milestones such as...QualifiedHourly payFull timePart timeApprenticeshipTraineeshipSeasonal workImmediate startAll shiftsFlexible hoursNight shift$164k - $226k
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- ...values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and... ...ACCELERATING YOUR FUTURE The Senior QA Specialist – Plant Operations... ...clearance and review and approval of GMP documentation including but not limited to Batch Records, Quality records, and...SeniorContract workWork at officeFlexible hours
$132k
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