LSC have a great contract opportunity for a Technical Writer 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 experience working in the pharmaceutical or biotechnology industry in technical writing/documentation and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
Develop and continuously improve the site documentation management strategy.
Draft, review and approve BPDs, SOPs, technical protocols and reports, forms, work instructions and other controlled documentation.
Produce accurate, high-quality documentation in line with data integrity, ALCOA and regulatory compliance requirements.
Act as an SME for Veeva Quality Documents and ComplianceWire, providing guidance and support to colleagues.
Collaborate with technical SMEs and cross-functional teams to ensure documentation accurately reflects technical and business requirements.
Support the transition of documentation into Veeva Quality Documents and assist with training materials, guides and e-learning modules.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
Third level qualification in a Science or Engineering discipline and/or extensive relevant technical writing experience.
Strong technical writing and document management experience within a regulated pharmaceutical or biotechnology environment.
Experience with GMP documentation, data integrity/ALCOA principles and systems such as Veeva Quality Documents and ComplianceWire.
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 Kathy Gillen at LSC on 021 4777329 if you have any more questions about this role!
