Lead QC Microbiology Specialist (Environmental Monitoring)

  • Contract
  • Dublin

Website Ref:TPM04679

Summary:
Our client, a bio pharmaceutical company located in Dublin, is looking for a Lead QC Micro Specialist. The ideal candidate will support qualification of a new production facility by writing qualification documents, SOPs and trend reports, among other duties.

Responsibilities:

  • Lead QC Technical documentation projects as an individual contributor.
  • Accountable for timely completion of projects within the technical writing role.
  • Collaborate with internal resources and business partners to support project requirements and ensure project completion.
  • Work in accordance with cGMP and GLP requirements.
  • Ensure consistent and good documentation practices are followed.
  • Creation, review, and update of documentation, e.g. Laboratory Technical Protocols and Reports, Standard Operating Procedures, and Analytical Protocols.
  • Translating complex topics into clear, concise, and understandable topics is required.
  • Review standards for documentation types, structure, and assembly so that content is organised logically with the end reader in mind.
  • Maintain Documents in the document management system.
  • Support QC Specialist with risk assessments/procedures for new facility.
  • Working with the project team to ensure we have sufficient resources and equipment for the project.
  • Completing qualification works for the new isolator, media qualification, along with others.
  • Reading & review of Environmental Monitoring (EM) plates.
  • Execution of EM PQ of new facility.

Qualifications & Experience:

  • Bachelor’s degree in a science discipline.
  • Biopharmaceutical QC experience in Environmental Monitoring.
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
  • Experience in technical writing.
  • Experience working in an aseptic cleanroom.
  • Proficient in the use of LIMS & LMES.
  • Technically strong background in microbiology and aseptic manufacturing.
  • Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage.
  • Experience with Regulatory inspectors and interacting with inspectors desirable.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.