I am thrilled to partner with a Dublin client to recruit a highly motivated Senior Associate Quality Assurance for an exciting contract opportunity within their Incoming Quality Assurance team.
As a key member you will be instrumental in ensuring the quality and compliance of primary packaging components crucial for the manufacture of life-changing aseptic products. Reporting to a QA Senior Manager, you will be the dedicated Quality point of contact for all aspects of incoming inspection.
Your Key Responsibilities will include:
- Conducting rigorous testing of primary and secondary components to ensure adherence to stringent quality standards.
- Performing meticulous sampling of Excipients and Drug Substance under controlled Grade C conditions.
- Expertly reviewing and approving critical documentation related to component testing, paving the way for QA Specialist or Qualified Person disposition.
- Taking ownership of minor Non-Conformances and CAPAs, from compilation and review to approval and closure, ensuring robust root cause analysis and achievable implementation plans.
- Providing invaluable training and expert advice to colleagues on component and packaging testing procedures.
- Actively participating in internal and external audits, contributing to their thorough preparation and successful execution.
- Conducting comprehensive reviews of cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOPs) to guarantee unwavering compliance.
- Developing, reviewing, and approving Standard Operating Procedures in alignment with the client's global policies.
- Upholding the highest safety standards and adhering strictly to SOPs in all activities.
- Contributing actively to continuous improvement and Operational Excellence initiatives, driving efficiency and quality enhancements.
- Undertaking additional tasks and projects as required by the QA Senior Manager.
What you need to succeed:
- Crucially, you must pass eye tests required for visual inspection.
- A relevant University degree, ideally in an Engineering or Science-related discipline.
- A minimum of 4 years of relevant experience working within the pharmaceutical or biotechnology industry, or a comparable combination of experience and education.
- Strong organizational skills with a proven ability to manage assignments through to successful completion.
- Demonstrated aptitude for problem-solving and experience in managing Root Cause Analysis, Non-Conformances, and Deviation investigations.
Preferred Skills and Experience:
- Excellent written and verbal communication skills, enabling clear and effective interaction at all levels.
- Proven experience collaborating effectively within dynamic cross-functional teams, with demonstrated decision-making abilities.
- Experience working within aseptic operations, protein formulation, and vial and syringe filling processes would be highly advantageous.
The Opportunity:
This is an exciting 12-month contract opportunity with the potential for extension, offering you the chance to work with a leading global organization at their state-of-the-art facility in Dun Laoghaire. The role requires an on-site presence with a defined shift pattern (approximately 20% of the time):
- Early Shift: Monday to Thursday (07:00 to 15:00), Friday (07:00 to 14:00)
- Late Shift: Monday to Thursday (14:30 to 22:30), Friday (13:30 to 20:30)
Ready to take on this challenging and rewarding role? Apply today by submitting your CV
