Overview
QA Snr Associate Jobs in Dublin, County Dublin, Ireland at Berkley Group
Title: QA Snr Associate
Company: Berkley Group
Location: Dublin, County Dublin, Ireland
QA Snr Associate
Job Overview:
As the Quality point of contact for manufacturing and inspection operations, the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.
This 24/7 shift role demands a 12-hour shift pattern (4 on, 4 off) to support manufacturing operations.
Key Responsibilities:
- Ensure adherence to safety standards and SOPs in all activities.
- Review and approve production batch records and associated documentation for Qualified Person disposition activities.
- Provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.
- Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
- Offer Quality Assurance support for on-the-floor investigations and deviations.
- Review and approve deviations for closure, ensuring compliance with appropriate documentation.
- Participate in customer complaint investigations.
- Conduct routine Quality Assurance walks on the production floor.
- Review and issue logbooks, ensuring compliance with procedures.
- Provide training and guidance to staff for effective performance.
- Review and approve cGMP records, ensuring compliance with appropriate documentation.
- Support continuous improvement and Operational Excellence initiatives.
- Undertake other tasks/projects as assigned by the manager.
Basic Qualifications & Experience:
- University degree in an Engineering or Science-related discipline (preferred).
- Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.
- Exceptional written and verbal communication skills.
- Proven experience collaborating with dynamic cross-functional teams and strong decision-making abilities.
- Robust organizational skills, with a commitment to seeing assignments through to completion.
- Demonstrated problem-solving abilities, particularly in supporting non-conformance/deviation investigations.
- Experience in inspecting vials and syringes and engaging in aseptic operations.
- Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; 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 contact David O’Connell on +353 86 1263871 or send your CV to [email protected]
