LSC have a great contract opportunity for 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. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
- Lead and represent Validation in multi-departmental meetings & project teams.
- Identifies and implements improvements to the QA Validation systems.
- Participation in the change control program for modifications to qualified systems.
- RVE responsibilities include the following: performance of detailed system review, generation of RVE documentation, scheduling & coordination of each RVE, performing and/or coordinating revalidation testing, completion of validation documents, etc.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
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 Sarah Ninan at LSC on 021-4777329 if you have any more questions about this opportunity!