Technical Writer - GMP - Biopharmaceuticals

Would you be interested in joining a state-of-the-art Biologics manufacturing organisation based in Cork?
Do you have excellent communication skills with the ability to work with multiple teams? 
Do you have expereince of Technical GMP writing?
We are looking for an experienced Technical Writer for a 12 months + contract to be based in Cork. 

You will be responsible for the following:

• Working closely with various teams such as: QC, QA, Manufacturing, Process Sciences, & Engineering etc collaborating with Subject Matter Experts (SME’s)  to draft, author and approve the  GMP Project documents & other non GMP project documents for various functional departments
• Document types may include:-
• (SOP's )Standard Operating Procedures for manufacturing operations
• Batch Records for Cell Culture and Purification operational steps.
• Process Design documents such as Unit Operation Reports and Process Design Documents.

 
To be successful for this role we are looking for the following skills & experience 

• Experience Drafting and Authoring GMP documents (ESSENTIAL)
• Experience with Trackwise (standard industry software)
• Document Management experience
• Excellent communication skills

Call me for further details on this role.

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