LSC have a great contract opportunity for a QA Specialist to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES
- Provide Quality direction and oversight of the development and continuous improvement of new and existing processes / systems to meet customer needs.
- Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
- Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
- Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements and minimising impact to Lot Release operations on site.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
- Demonstrated experience in Sterile Drug Product Filling and start-up of same.
- Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
- Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Jenny Murphy at LSC on 021 4777329 if you have any more questions about this role!
