LSC have a great contract opportunity for a QA IT Specialist to join a global Biopharmaceutical company in Cork. The facility specialises in the fermentation, purification and sterile filling of biotech products, as well as supporting product development and clinical trials.
If you have min. 5 years of experience in QA IT/CSV, CSV and/or a similar role in the pharmaceutical industry and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Providing independent quality review and approval of system lifecycle documentation, such as plans, requirements, risk assessments, test protocols and reports for new and modified systems.
o Liaising with the global and the pilot site QA IT leads for the project to ensure that the system rollout on site follows the global VMP.
o Providing independent quality review and approval of system changes.
o Supporting and approving computerised systems investigations and deviations.
o Ensuring consistent approach to qualification, change and deviation management.
o Managing and prioritising day-to-day activities through active alignment with the project team, and supporting other areas as needed.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Expert knowledge of relevant regulations and industry standards.
o Proven ability to meet timelines, prioritise tasks and engage with stakeholders.
o Excellent communication skills.
o Project management experience will be an advantage.
o LabX experience will be an advantage.
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!
To apply, submit your CV via this advert or contact Paul O’Driscoll at LSC on 021-4777329 if you have anymore questions about this QA IT Specialist opportunity!