Proclinical is currently recruiting for a QC Microbiologist with a pharmaceutical company located in Switzerland. The job holder provides routine QC Microbiology laboratory, with the purpose of meeting daily routine requirements as well as achieving goals established by the supervisor and/or manager.
- Provide microbiological testing of finished products, incoming materials, environmental monitoring samples, and utility samples.
- Adhere to all EHS policies. Promote Safety culture by on-time reporting of incidents, and identification of ZAPS and HAZ IDs.
- Perform cGMP testing of utilities, bulk/finished products, and validation samples utilising established methods. Examples of test types include: Endotoxin, Bioburden, Sterility, Microbial Identification, Biological Indicator testing, and Growth Promotion.
- Provide accurate results and interpret data in compliance with cGMP's, procedures and all applicable regulations.
- Testing may occur on first and second shifts and may include weekend and/or holiday work
- Review Microbiology within established timelines.
- Ensure all equipment, supplies and reagents are available and in a GMP state to support testing that is right-first-time and on time. Execute reagent, standard qualifications as required.
- Perform data review/logbooks reviews; manage to ensure releases meet SLA timelines.
- Become knowledgeable of Microbiology tests/processes. Evaluate micro tests/processes, and optimise to incorporate GSK best practices, incorporate efficiency, and address regulatory gaps.
- Participate in investigations and planned remedial actions for atypical events and/or results in order to support the timely resolution of investigations. Author associated documentation
- Write, update, and review Laboratory Standard Operating Procedures, Analytical Methods, Specifications and other GMP documents.
Skills and Requirements
- B.S in Microbiology, Biochemistry, or similar scientific discipline.
- Minimum 1 year of experience in a GMP/ GLP regulated environment.
- Minimum 1 year of experience in Quality Control environment in a microbiology/chemistry/biochemistry field.
- Prior work experience and/or able to perform some or all of the following: Endotoxin, sterility, growth promotion, microbial IDs. Endotoxin experience is a must.
- Versed in GMPs, FDA and other regulatory agency requirements. Ability to interface with regulatory auditor.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.