LSC have a great contract opportunity for a QA Validation Specialist to join a Cork based Biopharmaceutical company.
If you have 3+ 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:
- Provide project management oversight for validation activities related to company products, process, equipment and cleaning validation activities.
- Develop validation plans for specific system implementation projects.
- Execute (protocol generation, execution, and final package preparation and reports) validation activities related to the implementation of process, equipment, CSV, cleaning, procedures and practices to establish approval criteria, and identify and implement solutions.
- Represent Validation in multi-departmental meetings & project teams.
- Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- 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 Conor Dolan at LSC on 021-4777329 if you have anymore questions about this QA Validation Specialist opportunity!