Biologics Quality Assurance Specialist

2 weeks ago


Dundalk, Louth, Ireland Wuxi Biologics Ireland Limited Full time

About the Company:

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Wuxi Biologics Ireland Limited is a leading provider of biologics services, offering a comprehensive range of solutions from discovery to commercialization. With a global presence and a commitment to excellence, the company has established itself as a trusted partner in the biopharmaceutical industry.

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About the Job:

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The QC Microbiology Team Lead will play a crucial role in ensuring the quality and safety of our biologics products. This position requires a strong understanding of microbiological principles, laboratory procedures, and regulatory requirements.

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  • Ensure the tasks associated with the startup and routine operations of a QC microbiology laboratory are carried out in a safe manner">
  • Support QC Microbiology lab set-up, including laboratory design and construction queries, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs">
  • Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc.">
  • Develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP">
  • Support of the commissioning/qualification activities of utility systems including but not limited to Water systems, Clean Steam and process gases, including development of sampling strategies">
  • Aiding in the identification and development of Contract Test laboratories and strategies">
  • Development of training material for the QC Microbiology Laboratory personnel">
  • Support and lead microbial method validation and development of routine testing strategies">
  • Lead QC microbiology routine testing, environmental monitoring, water monitoring, and testing including, sterility, endotoxin, bioburden, Biological Indicators, Growth promotion and routine microbial identification strategies">
  • Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs">
  • Author technical documents including methods protocols, qualification/validation protocols and reports, SOPs, etc.">
  • Support Risk Assessments for projects and business innovation initiatives from a microbiological perspective">
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About You:

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We are looking for a highly skilled and experienced microbiologist to join our team. The ideal candidate will have:

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  • Detailed knowledge of routine and non-routine testing and sampling methods, techniques, and related equipment">
  • Familiarity with pharmacopeia testing methods and requirements">
  • Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines are a plus">
  • Experience with regulatory/customer audits is a plus">
  • Experience in managing/supervising personnel, with particular attention to schedules and shifting priorities">
  • Training/coaching of personnel">
  • Previous experience in a Quality Control/GMP environment is required">
  • Knowledge of microbial testing and microbial control in support of biopharmaceutical manufacturing is preferred but not required">
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Benefits:

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We offer a competitive salary package, including bonuses, life assurance, paid holidays, parking, pension, and VHI.



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