QC Analyst is required for a leading pharmaceutical company in Cork. Our client specialises in the manufacture of small molecule APIs in three production facilities on site, one of which is sterile. This site has been producing APIs for over 35 years in Cork and has developed a reputation as being innovative, adaptive and having a clear strategic vision. The site has added to its core functions over the years and is now a key decision maker in the company’s global supply chain. The site is going through a series of upgrades and investments in 2016/17 which will add to its current capabilities and strengthen its long term strategic plan.
The QC Analyst will be responsible for:
o Achieves competency in laboratory methods and procedures.
o Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
o Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
o Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
o Review and approval (where appropriate) of laboratory test results.
o Writes and reviews laboratory TMs, SOPs and WIs as directed by company policy.
o Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
The QC Analyst requires:
o A third level qualification of a scientific/technical discipline is required.
o 2 years’ experience in a similar position is required.
o Expert in wet chemistry testing techniques
o Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Call Amparo in LSC 021 4777 329 for more details on this new QC Analyst role or apply directly via this advert.