LSC have a great contract opportunity for a GMP Coordinator 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 2+ years of experience in Quality Management Systems within a GMP environment and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Support regional leads and local teams with the coordination, communication, planning, preparation and submission of site GMP and compliance-related content pertaining to Marketing Application(s) and Establishment Licenses for initial/renewal applications in Global markets aligned with regulatory strategy
- Be the point of contact between Local Regulatory Teams and SMEs/CMOs to support GMP/site registration submissions.
- Coordinate Power of Attorney and other signature/legalization process
- Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements
- Update relevant dashboards on progress of regulatory document preparations working closely with Regulatory and Quality partner
- Interfacing with global Regulatory partners, internal cross functional teams, and consultants
- Process documentation requests to support key application activities
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BA/BS degree in life sciences in chemistry, molecular biology, or similar is desirable
- At least 2 years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global Pharmaceutical and/or Biotechnology Company (preferably with exposure to both development and commercial phases of product lifecycle).
- Outstanding interpersonal and communication (written and verbal) skills is required.
- Proficient with computer and standard software programs
- Ability to work across the Global time zones
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you for your understanding.
Apply via this advert or contact Gráinne Hodnett at LSC on 021-4777329 if you have any more questions about this opportunity!
