LSC have a great contract opportunity for MSAT 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.
If you have 5+ years' experience in a cGMP regulated manufacturing environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Developing validation plans and rationale for process, packaging and shipping validation activities.
- Responsible for shipping validation of products through the various GMP manufacturing nodes across BioMarin
- Execute (protocol generation, execution, and final package preparation and reports) validation activities related to shipping validation.
- Lead and represent MSAT Validation in multi-departmental meetings & project teams.
- Assist with preparation of regulatory filings, responding to questions from regulatory agencies, and with presentation of materials during regulatory inspections /partner audits.
- Participation in the change control program for modifications to qualified processes.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
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!