LSC have an exciting contract opportunity for a Compliance Specialist to join a leading Biotech company based in Dublin.
If you have minimum 5 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Lead the preparation activities for the submission of the site Manufacturer’s Importation Authorisation (MIA)/Commercial GMP license application
o Lead the preparation of the Site Master File and associated site documentation required as part of MIA submission
o Support for related Compliance deliverables in support of audits and inspection readiness
o Support for Recall QMS topic
o Provide Quality and cGMP input and support for audit and inspection readiness activities
o Support the site Document / SOP management systems
o Support for various GMP and Quality Training programs & Knowledge Management activities
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)
o Experience in startup facilities a distinct advantage
o Experience of MIA submissions, Site Master File compilation and electronic quality management system tools is required
o Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements
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 Katie Brown at LSC on 021-4777329 if you have anymore questions about this Compliance Specialist opportunity!