Quality Assurance Specialist -Clare/Galway
Quality Assurance Specialist
Fancy working in a new state of the art pharma company in the Mid -West region with proximity to Shannon Airport/M18/Galway/Limerick? I am both privileged and excited to be assisting this new clinical-stage gene therapy company in the Mid -West to recruit for a Senior Quality Assurance Specialist .
This company has invested millions into their site which shows their long-term commitment to employees and the area. This is a superb opportunity to work in an innovative and friendly pharma company that serve patients with life-improving treatments, you will have the opportunity to partner with leading institutions around the world . Your work will truly make a difference to people's lives, and you will work alongside cutting-edge technology and a supportive and friendly team. Working here will be a fantastic addition to your CV.
What you will be doing:
Your role will involve ensuring all aspects of GMP are adhered to in the QC Analytical Department in relation to testing, equipment qualification and validation, documentation.
- Review/approval of GMP Documents in the QC Analytical Department.
- QA Oversight and support for any GMP issues arising from within the QC Department.
- Provide quality oversight of analytical testing and validation.
- Review and support OOS investigations or GMP non-compliances
- Leadership/oversight to the QC Data Integrity program, ensuring that the QC labs are consistently operating to current GMP expectations for DI.
- Responsible for ensuring that work complies with GMP, Data Integrity and Good Documentation Practice (GDP)
- Ensure training of the team is undertaken in a timely and GMP compliant manner
- Ensure that GMP documentation e.g., CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
- Responsible for ensuring that the Quality Systems support QC in operating to cGMPs. Continually monitor the QMS and implement improvements for QC where required
- Work closely with the QA team in developing and maintaining the site QMS to cGMP.
- Degree in an Engineering or Science discipline
- A minimum of 3 years' experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry.
- Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Internal audit experience
You will be remunerated with an attractive salary package to include healthcare, dental care, enhanced annual leave days, pension, bonus scheme, share option scheme, relocation package available for candidates outside of Ireland .
Your Next Step
To apply for this Senior Quality Assurance Specialist job , please submit your CV(Word) through this website now in the strictest of confidence.
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