Quality Specialist - Pharma
- BBBH789730 Sep 10, 2021 Competitive
An excellent opportunity for a QA professional to join one of Cork's most innovative pharma businesses. This is an all encompassing QA role
I am delighted to be able to bring this opportunity to market for a innovative client based in East Cork. This opportunity is with an international company who have strong roots in Ireland and are on the look out for an experienced Quality Specialist to join their team. This is an FDA approved, GMP regulated facility so experience within a highly regulated environment is a must. This role will be responsible for ensuring compliance to new and established systems and global regulations and guidelines for a wide product portfolio.
What makes this different to other QA specialist opportunities is the exposure to the whole manufacturing process. Being part of the QA team here means that you get to experience everything from RM goods in to packing and distribution. They are a company that pride themselves on educating and developing their workforce. This upskilling leads to further internal opportunities and promotions as proven by many of their workforce today.
- Ensure compliance to new and established systems, global regulations and guidelines for a wide range of DPIs, APIs and intermediates;
- Issuance, control and review of production batch records;
- Batch record review
- Lead and participate in validation activities including issuance of process validation protocols and reports
- Participate in cross functional teams for the introduction of new products/processes;
- Preparation/approval of cleaning documentation;
- Participate in cross functional investigations, advise on corrective actions and assist with their implementation;
- Carryout GMP training;
- Participate in all aspects of audits by Regulatory Authorities and Customers and Conduct internal audits as per agreed schedules;
- Degree in a technical or scientific based subject - Chemistry, Biochemistry, etc.;
- Minimum of 3 years in a QA Specialist or Compliance Role in a Regulated Pharmaceutical Industry;
- Competent and knowledgeable of all relevant ICH guidelines, particularly ICH Q7A, EU GMP guide annex 18, and all FDA requirements relating to 21 CFR 210 and 21 CRF 211;
- Excellent communications skills;
- Flexibility is essential;
- Proven ability to work on own initiative;
If this sounds of interest, or if you would like to hear more then click the 'Apply Now' button below or reach out to Kellie on firstname.lastname@example.org or 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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