Pharmaceutical & Biotechnology
Micro Analyst
- Contract
- Cork, County Cork, Ireland
- 42034511
Description:
PE Global is currently recruiting for a QC Micro Analyst on behalf of a leading biotech company based in Cork. This is an initial 12-month contract and a 2-shift cycle role.
Overview:
The candidate must have superior technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product. The candidate must have prior experience of working in an IMB/FDA regulated facility.
Responsibilities:
- Reporting to the QC Team Leader
- 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
SPECIFIC TESTING EXPERIENCE REQUIRED
- Bioburden
- Endotoxin
- Sterility testing
- Microbial Identification using genetic methods
Education and Experience:
- BSc (Honors) in a scientific/technical discipline.
- A minimum of 2 years’ experience within the Pharmaceutical Industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
- Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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