Job Description
I have an excellent opportunity for a Senior QA Aseptic Specialist to join a leading biopharmaceutical company based in Dublin on a permanent basis.
This person will be the shift lead for their team on a a 24/7 shift cycle.The successful person will have experience in a Pharmaceutical finished drug product manufacturing environment with working knowledge of EU GMP and US FDA. You must have a biologics background for a minimum of 5 years. A degree in a science or quality-based discipline is essential. The ability to influence and communicate across the team is important for this role.
Responsibilities:
1. Front line support in the graded areas with oversight of end-to-end aseptic operations in the manufacturing areas.
2. Critically evaluate and implement continuous improvements within the aseptic processes.
3. Perform all activities in compliance with the safety standards and SOPs.
4. Represent QA on multi-site workstreams related to Aseptic Compliance
5. Own and drive QA led improvement projects.
6. Provide Quality direction and input at Deviation and Change Control Review Boards and assume oversight of Deviation, CAPA and Change Control records.
7. Write, review, and approve Standard Operating Procedures in accordance with Policies.
8. Participate in site activities associated with QMS programs and provide active input into shaping the future direction of these systems.
9. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation.
10. Participates in customer complaint investigations.
11. Quality Aseptic Specialist point of contact during batch manufacture.
12. Aseptic oversight during sterile formulation and filling.
If this role is of interest to you, please apply now or contact me on 021 2300 300 or at
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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