Responsible for the carrying out routine microbiology laboratory activities including environmental monitoring of cleanrooms; microbial analysis of site utilities and testing of raw material, commercial, clinical and development batches. Further, the position holder will manage the microbial analysis of the companies products included in the Global Stability program. Microbial monitoring and testing is performed in line with regulatory requirements.
- Perform key tasks for release and stability testing such as:
- Environmental Monitoring
- water sampling
- growth promotion
- in-process testing
- Sterility testing
- Antibiotic Assay
Essential Skills, Experience, and Competencies:
- Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of sterile products.
- Performs routine and non-routine Microbiological testing activities as required.
- Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
- Ensures activities are carried out in compliance with product license commitments, cGMP, company quality standards and legislative regarding health, safety and environment.
Education and Experience
- 3rd Level Qualification in Microbiology or equivalent scientific degree
- 12 months working in a manufacturing environment. Preferably Aseptic processing.
- Working knowledge of both Pharmaceutical Industry and sterile processing.
- Strong background in Aseptic’s and/or Microbiology