DOCUMENTATION SPECIALIST – 12 month CONTRACT, to be located in Co. CORK.

The Documentation Specialist is responsible for the smooth execution of all appropriate documentation.

Key duties & responsibilities:

• Updating of procedural documents
• Preparation of change control documentation
• Processing of documentation through the Change Control System
• Review of batch records and recording of incidences of corrections made to batch records
• Generation and control of protocols
• Quality & Safety Compliance monitoring including reporting, metrics, etc
• Investigation Support
• Any other duties assigned by your lead.

What are we looking for?

• Relevant 3rd level Qualification – i.e. Science
• Minimum 4 years’ experience of working in similar documentation related role within pharma
• High level technical writing skills
• Advanced PC skills – Excel, MS Access, Word, PowerPoint
• Familiarity with automated approval systems i.e. Trackwise, Documentum etc.
• Strong Communication & interpersonal skills with strong attention to detail
• High level of technical aptitude
• Good understanding of CGMP and able to meet deadlines and follow strict SOP’s
• Knowledge of EU/US quality related pharmaceutical regulations an advantage

Apply for this job now or get in touch with Carol on 059 9139070.

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