QC Micro

  • Cork
  • Temporary 12 months
  • JO-1908-64686_1565161541

Summary

Responsibilities

Reporting to the QC Team Leader the person will be responsible for the following;

  • Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
  • Rapid turnaround of samples to meet manufacturing needs.
  • Performing data review and approval.
  • Providing support and advice to manufacturing on QC related topics.
  • Initiating and leading investigations where required.
  • Initiates and completes, CAPAs and Change Controls in accordance with site procedure
  • Writes new and updates current procedures on electronic documentation system.
  • Providing training to other analysts and to manufacturing personnel.
  • Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
  • Proactively identifies and implements lab process improvements.
  • Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
  • Supports Team leader on day to day testing operations

Preferred testing experience:

  • Bioburden
  • Endotoxin
  • Sterility Testing
  • Microbial Identification using genetic methods

Requirements

  • Third-level qualification (Minimum: Primary degree in a science discipline).
  • A minimum of 2 years' experience within the Pharmaceutical Industry
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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