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QA Specialist - Operational Excellence, Dublin South
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Location:
Dublin South, Ireland
Job Category:
EU work permit required:
Yes
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Job Reference:
5084792_1752058026
Job Views:
17
Posted:
09.07.2025
Expiry Date:
23.08.2025
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Job Description:
Global Biotechnology company, based in south Dublin, Ireland – looking for Quality Assurance Specialist.
Successful candidates will typically be educated to degree level in a Scientific or related discipline and ideally will have acquired technical skills and demonstrated competencies across a broad range of quality related disciplines.
QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.
The role:
* Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process.
* Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
* Oversee and implement Quality Agreements relating to area of responsibility.
* Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines associated with company Quality Systems.
* Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or corporate policies & procedures.
* Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework.
* Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management.
* Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy.
Have You:
* University degree. Engineering or Science related discipline preferred.
* Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making.
* Strong organizational skills, including ability to follow assignments through to completion.
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
* Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to [emailprotected]
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