Doc Specialist

Desired Skills: MS Office Suite,Doc control,Tech Writing,Compliance,Science,Engineering

The Role

PE Global are recruiting for an Operations Compliance Specialist for our biotechnology client based in Ringaskiddy Co. Cork. This is an initial 12 -month contract role. Hybrid working options.

Job Responsibilities

• Manage the authoring & drafting of all types of Manufacturing Operations documentation.
• Specifications & associated forms in conjunction with the various departmental subject
  matter experts (SME)
• Support document updates and manage timelines for cross functional Projects.
• Act as a SME/Superuser on the Controlled Document System to facilitate the processing & approval of documents.
• Organise & Facilitate Document Round Table meetings with cross functional teams as
  required
• Mange and build Quality Veeva QMS metrics for Manufacturing Operations
• Coach & Train colleagues in Documentation System & GDP queries
• Support manufacturing operations on meeting deadlines on Veeva QMS records
• Update compliance procedures and processes.
• Generate Reports/Metrics & analyze trends as required including but not limited to:
  Veeva QMS reports, Doc Tracker Lookaheads, ASI/AIC metrics, Logbook Metrics,
  Doc Tracker Metrics, RFT Metrics.
• Perform Logbook Training, review, and trending of all closed logbooks, identifying issues and managing timely archiving.
• Train and perform Area Self Inspections & Generate ASI schedule.
• Train Manufacturing colleagues in GDP/GMP
• Management of Veeva paper Binders
• Continuous monitoring of Compliance in Manufacturing.
• Facilitate all internal and external Inspections.
• Participate in permanent inspection readiness by completing Inspection walkthroughs within manufacturing operations.

Education & Experience

• 2+ years’ experience in technical writing and compliance
• Proficient in data analytics, data visualization
• Working knowledge in Regulations, GMP, GDP
• 2+ working within a regulated healthcare industry including a role in capacity of quality and compliance.
• Strong verbal, written and oral communication skills.
• Able to work independently and be flexible to changing priorities

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****