Quality Assurance Manager

6 giorni fa


Lazio, Italia Michael Page International Italia S.R.L. A tempo pieno

Philogen S.p.A. is a biotechnology company dedicated to developing targeted products for the imaging and treatment of life-threatening diseases, with a strategic focus on oncology.Our mission is to translate cutting-edge scientific innovation into effective therapies that improve patients' lives.Position OverviewPhilogen S.p.A. is seeking a Microbiological Quality Control Analyst to join the Quality Control Department.The successful candidate will perform microbiological testing and environmental monitoring activities in compliance with Good Manufacturing Practice (GMP) standards, supporting the quality and safety of our biopharmaceutical products.Key ResponsibilitiesPerform microbiological analytical methods including:Growth Promotion Test (GPT)Biological indicator testingSterility testingConduct environmental monitoring activities in classified manufacturing areas, including sampling, incubation, and testing.Perform sampling and microbiological testing of water systems, including Water for Injection (WFI), Clean Steam, Purified Water, Softened Water, and Drinking Water.Execute microbiological quality control of finished products and in-process samples.Prepare, review, and maintain protocols, reports, and Standard Operating Procedures (SOPs).Compile and manage data forms, registers, and certificates in accordance with internal procedures.Ensure proper management, calibration, and maintenance of laboratory instruments.RequirementsDegree in Biology, Biotechnology, Pharmacy, or a related scientific discipline.Solid scientific background and technical competence in microbiological analyses.Proven experience in a similar role within a GMP-regulated pharmaceutical or biotechnology environment.Strong knowledge of GMP principles and quality system requirements.Excellent attention to detail, with the ability to prioritize tasks and manage workload efficiently.Capability to work independently and to coordinate team members when required.Strong interpersonal and communication skills, with a collaborative and proactive attitude.What We OfferA professional and supportive work environment focused on scientific excellence and teamwork.A contract and salary commensurate with the candidate's experience and seniority.Opportunities for professional development within an innovative and growing biotechnology company.#J-*****-Ljbffr



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