Quality Assurance Specialist
CK Group are recruiting for a Quality Assurance Specialist to join a biopharmaceutical company at their site based in Carrigtwohill, near Cork on a contract basis for 10 months and has an hourly rate of up to €26.71 depending upon experience.
Our client is a biopharmaceutical company that discovers, develops and commercialises innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Their Ireland operations are responsible for manufacturing, quality control, packaging, and the release and distribution of the company's products in the European Union and other international locations.
This role will be based at our clients manufacturing site in Carrigtwohill. Carrigtwohill, officially Carrigtohill, is a town in County Cork, Ireland with a population of 5,080. It is 12 kilometres east of Cork city and can be accessed via the N25.
This role is a QA Specialist contract role working under the QA Training and Systems team. This specific role is required to support a team of 8 training and systems analysts, this role may require project support on improvements to QA systems. This candidate will be required to exercise judgment within well-defined and established procedures and practices to determine appropriate action, to identify problems and to generate alternatives and recommendations within defined processes.Key Responsibilities:
- Perform a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participate in developing and approving Standard Operating Procedures (SOPs).
- Review and approval of GMP Deviation investigations and CAPAs.
- Perform internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP.
- Perform QA site system support across a number of QA systems.
- Participate in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings.
- Normally receives very little instruction on routine work, general instructions on new assignments.
To succeed in this role you will have a working knowledge of GMP, quality assurance systems and FDA/EMEA standards. You will also have basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
For more information or to apply for this QA Specialist position, please contact Natasha on +44 1438 870011 or email firstname.lastname@example.org, quoting job ref 48005.
It is essential that applicants hold entitlement to work in Ireland.