Validation Specialist - Biopharmaceutical - Dublin
LSC have a great contract opportunity for a Validation Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products.
If you have a minimum of 8 years' experience in the biopharmaceutical or pharmaceutical industry (Validation, Technical Services or Quality) and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Develop and support the implementation of scientifically sound, fit for purpose standards and procedures for process, cleaning validation, continued process verification and other technical procedures based on current regulations, industry standards and industry practices. Deliver associated training to colleagues.
- Support the implementation of innovative and efficient approaches to validation by company internal and external sites incorporating science and risk-based approach.
- Work closely with process and analytical development teams to ensure that the validation framework is consistent with the global strategy.
- Support the development and implementation of process validation plans in collaboration with the validation and technical SME network.
- Review and approve cGMP documents including, but not limited to, validation master plans, protocols and reports.
- Provide validation expertise for assessment of changes, deviations, CAPAs and audit findings.
- Build strong cross functional working relationships with stakeholders (Quality, Development, Technical Services and CMOs) to ensure high quality deliverables meeting cGMP and company validation requirements
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- A minimum of 6 years' direct experience in cGMP validation activities.
- Extensive knowledge of Validation regulations, current industry practices, and experience of interpretation and application of guidelines and regulations.
- Excellent technical writing skills
- Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish.
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 Conor Dolan at LSC on 021-4777329 if you have anymore questions about this Validation Specialist opportunity!