Associate Documentation Analyst
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| Job Type | Contractor |
| Area | Mayo |
| Sector | QualityLaboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2432 |
| Job Views | 252 |
- Description
- We are seeking applications for an Associate Documentation Analyst for our client who is a leading pharmaceutical company based in Mayo on a 9-month contract. An Associate Documentation Analyst is a member of the Document Control Department. The Document Control department in turn forms part of the QA group locally. The Document Control group is responsible for the processing of all One Vault Documentation for the Westport site. Document Control must maintain compliance with local, regulatory and legislative requirements with regards to Safety, Housekeeping, GMP and support and comply with internal environmental health and safety requirements, procedures and policies. It achieves these functions by interaction with QA, EHS, Compliance and regulatory affairs to ensure all internal procedures reflect current requirements.
What you will be doing:
Monitor and coordinate content development across all manufacturing workstreams.
Redline and update/obsolete SOPs, Controlled Forms, Project Documents and Manufacturing Records relating to the OMI project and submit on One Vault for Processing.
Process above documents from Draft to Effective/Obsolete on One Vault as per internal procedures.
Initiate training on all SOPs using LMS/Compliance wire system.
Update and distribution of internal department documentation when necessary
Run One Vault and LMS reports relating to department and other departments as required.
Maintain all current KPI metrics at or above targets.
Ensure Document Control is in compliance with all procedures at all times.
Deal with Internal and External customer queries under the guidance of the department Supervisor.
What you need to apply:
Proven track record in a quality discipline in the Pharma/Medical Device environment.
Microsoft Office Word and Excel is essential.
Clear understanding of working within a regulated environment
Excellent communication skills
Ability to use sound judgment to make effective decisions within appropriate timeframes.
