Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for a Deviation Specialist to join their team in Dublin for their new large-scale facility.
This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Serve as a Quality SME for site deviation management system
- Support the review and approval of site deviation and investigations reports.
- Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations
- Day to day management of Deviation and CAPA metrics
- Support internal and external audit preparations regarding deviation management system
- Support the delivery of site deviation training
- This role requires a minimum of 3 years experience in, Quality Assurance,Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
- A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends relating to deviation investigations and CAPA identification.
- Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
- Must have at least 3 years of experience of deviation systems and investigations in a regulated environment.
- Must have experience of compiling and reporting QMS metrics.
- Experience with SAP desirable.
Please apply today for immediate consideration.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Republic of Ireland
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