Micro Technician/Analyst
The Microbiology Technician is 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 Allergan products included in the Global Stability program. Microbial monitoring and testing are performed in line with regulatory requirements.
Responsibilities
- Perform key tasks for release and stability testing such as:
- Environmental Monitoring
- Water sampling
- In-process testing
- Endotoxin
- Growth promotion
- Sterility testing
- APET
- Antibiotic Assay
- Report writing
- Draft and review documentation –SOPs, protocols, training modules, investigations, reports, CAPAs and deviations
- Trending of results and preform investigations into adverse or out of limit results
- Validation of equipment and microbiology test methods
Requirements
- 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
- 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.
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