LSC have a great contract opportunity for a QA Validation Associate 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.
If you have 5+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process and cleaning validation and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Provide project management oversight for validation activities related to products, process and cleaning validation activities.
o Developing validation plans and rationale for process and cleaning validation studies.
o Execute (protocol generation, execution, and final package preparation and reports) validation activities related to process and cleaning.
o Lead and represent Validation in multi-departmental meetings & project teams.
o Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
o Identifies and implements improvements to the QA Validation systems.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
o 5+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge and a high level of proficiency in process and cleaning validation.
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 Kathy Gillen at LSC on 021-4777329 if you have anymore questions about this QA Validation Associate opportunity!