Microbial Quality Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeePharmaceutical Full time €40,000 - €80,000
Job Overview

We conduct thorough evaluations to assess the effectiveness of antimicrobial preservatives in multi-dose pharmaceutical products, following established pharmacopoeial guidelines.

  • Water Analysis: We evaluate the microbiological quality of pharmaceutical-grade water, including purified water and water for injection (WFI), to ensure compliance with regulatory standards.
  • Species-Level Identification: Our team accurately identifies bacteria, fungi, and yeasts using biochemical and molecular methods.
  • Media Verification: We verify the performance of media to support microbial recovery in microbiological assays, as required by GMP guidelines.
  • Bioburden Testing: We quantify the bioburden of non-sterile drug products and raw materials to ensure safety.
  • Endotoxin Detection: We utilize the Limulus Amebocyte Lysate (LAL) assay to detect bacterial endotoxins and ensure injectable product safety.
  • Aseptic Testing: We conduct testing under aseptic conditions to confirm the absence of viable microorganisms in sterile pharmaceutical products.
  • Cleanroom Monitoring: We monitor cleanroom environments — including air, surfaces, and personnel — to ensure GMP compliance.
  • GMP Batch Release: We provide support for timely product release to market through microbiological batch release testing.
  • Microbiological Stability: We determine shelf-life and product robustness through microbiological stability testing under ICH storage conditions.
  • Method Development: We develop and validate microbiological methods tailored to meet specific formulation and regulatory needs.

Our team is dedicated to providing high-quality services that support your business objectives. If you are interested in this role, we would be happy to discuss further details and answer any questions you may have.

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