PE Global is currently recruiting for a Microbiologist for a leading multi-national Pharma client based in Cork.
This is a contract shift position.
Role: 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: 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.
PREFERED TESTING EXPERIENCE: Bioburden Endotoxin Sterility Testing Microbial Identification using genetic methods Requirements: The position of QC analyst requires a 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application.
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Skills: Bioburden Endotoxin Sterility Testing Microbial Identification