The QA Specialist will work in the EU Quality Operations in the Quality Assurance department.
You will support the Qualified Person function, contract manufacturing operations, supply chain operations, supplier quality functions & Artwork Management performed.
- Reviewing batch documentation, data, certificates of analyses, and providing supporting QP functions
- Supporting batch disposition
- Designing and implementing quality systems relating to batch disposition
- Maintaining and improving quality metrics
- Approving and leading deviations, change controls, CAPA, investigations and nonconformance reviews, etc.
- Supporting QC activities as they relate to product disposition
- Supporting the investigation of drug product complaints and support any recall efforts in conjunction with QP/RP
- Conducting external audits independently as lead auditor
- Author and implement Technical Quality Agreements
- Supporting Product Quality Review
- Participating in technology transfer, process scale-up, and process improvement projects.
- Leading meetings with external parties and representing the company in a professional manner.
- Supporting integration activities relating to product disposition
- Supporting maintenance and update of site licenses
- Supporting regulatory authority inspections
- Promoting an environment of continuous improvement
- 2 to 3 years working in Quality Assurance role to support the manufacturing of medicinal product.
- Thorough understanding of quality systems and cGMPs.
- Experience conducting audits as lead auditor
- Interpersonal skills and professional skills to interact with contractors
- Must be able to prioritize and multitask in a busy environment.
- Must be able to travel approx. 5% (domestic and international)
- Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
- Experience working with a Qualified Person or Responsible Person
- Experience interfacing with regulatory bodies or working on regulatory submissions.
- The position may require some travel, envisaged 2 days, 2 – 3 times per year.
- This position is responsible for leading, monitoring and supporting the quality performance of European quality systems according GMP & GDP standards.
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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