Reporting to the QC Team Leader the person will be responsible for the following;
- Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
- Rapid turnaround of samples to meet manufacturing needs.
- Performing data review and approval.
- Providing support and advice to manufacturing on QC related topics.
- Initiating and leading investigations where required.
- Initiates and completes, CAPAs and Change Controls in accordance with site procedure
- Writes new and updates current procedures on electronic documentation system.
- Providing training to other analysts and to manufacturing personnel.
- Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors etc.
- Proactively identifies and implements lab process improvements.
- Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
- Supports Team leader on day to day testing operations
Preferred testing experience:
- Sterility Testing
- Microbial Identification using genetic methods
- Third-level qualification (Minimum: Primary degree in a science discipline).
- A minimum of 2 years' experience within the Pharmaceutical Industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists