QC Micro Analyst (Shift)
RK9989
12 Months
Cork
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
* 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 to customers, i.e., internal investigations and regulatory inspectors.
* 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.
* Supports Team leader on day to day testing operations.
Education and Experience:
* The position of QC analyst requires a 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.
* Experience with Bioburden, Endotoxin, Sterility Testing, Microbial Identification using genetic methods.
If interested in this posting, please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.
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