QA Technical Officer
2 weeks ago
**Division**:Bisol/Nagor
**Location**: Cumbernauld
**Job Title**:QA Technical Officer (Microbiology)
**Department**: Quality
**Responsible to**:Quality Manager
**Purpose of Job** (Summary)
- Ensure that:
- All environmental control systems are appropriate and effective in controlling the risk of microbial contamination of products.
- Sterilization processes are appropriately validated and re-validated.
- Sterilized product meets all required sterilization and microbiological specifications.
- Manage and maintain all relevant quality actions and documentation.
- Release sterilized products based on review of relevant processes and documentation and ensure all products released meet the required microbial and sterilization specifications.
**Key Responsibilities**
- Design, implement and maintain systems and documentation to control environmental and product contamination levels.
- Monitor environment and product contamination levels and take appropriate action to minimise product contamination.
- Maintain validated sterilisation processes in accordance with current regulatory requirements.
- Ensure sterilization and microbiological release systems are effective and maintained.
- Ensure products meet all required specifications regarding sterilization and release.
- Support the in-house Dry Heat sterilisation process.
- To have the authority to halt product release due to unacceptable risk of contamination levels or sterility risks to the product.
- Assess microbiological risks.
**Qualifications / Experience**
- BSc in Microbiology or a related life sciences discipline.
- Experience working within a regulated industry e.g. ISO, GLP, GMP preferred.
- Experience within quality control and/or quality assurance preferred.
- Good communication and organizational skills.
- Ability to problem solve and work independently with limited supervision.
- Good computer and IT skills including; Word, Excel, PowerPoint and databases.
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