Senior QA Operations Specialist - Shift
24/7 shift - 35% shift premium
On Site - South Dublin
AMC4145
I am currently looking for a Quality point of contact for manufacturing operations at an award-winning Biopharmaceutical manufacturing facility in South Dublin.
This is a 24/7 shift role with 4 days on then four days off, shift premium and extra hours for working social hours. This is an excellent opportunity to develop in a QA role within Biopharmaceutical manufacturing.
If you have a BSc in a scientific discipline and 4+ years experience working within operations in Pharmaceutical and/or Biopharmaceutical manufacturing I would love to hear from you!
Key Responsibilities:
1. Perform all activities in compliance with safety standards and SOPs.
2. Write, review and approve Standard Operating Procedures in accordance with Policies.
3. Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
4. Review and approval of deviations for closure ensuring compliance with appropriate documentation.
5. Participate in customer complaint investigations.
6. Provide training and advice to staff to enable them to perform their desired functions.
7. Observe and provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe fill finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
8. Review/approve production batch records and associated documentation in preparation for Qualified Person disposition activities.
9. Review and approve cGMP records ensuring compliance with appropriate documentation.
10. Support continuous improvement and Operational Excellence initiatives.
Requirements
1. University degree in Engineering or a Science-related discipline.
2. Relevant experience (4+ years) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
3. Demonstrated ability in problem-solving and experience in managing Root Cause Analysis / Non-Conformance / Deviation investigations.
4. Experience working in aseptic operations, protein formulation, vial and syringe filling.
5. Knowledge of applicable Regulatory requirements and ability to evaluate compliance issues.
Apply today or get in touch with Angela McCauley at Life Science Recruitment for more information.
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