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Documentation Control Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Scientific
  • Date posted: 08/06/2017
  • Job reference: J367978A
This vacancy has now expired.

Documentation Control Specialist

Job type: Permanent
Location: South Ireland
Salary: Neg

Purpose of Role

In this position, your role would be to ensure the storage, issuance and retrieval of all controlled documents are managed in a manner which meets cGMP requirements.

The ideal candidate would have previous experience working within a pharmaceutical industry in a similar position with strong Document Management and Administrative skills.

Job Requirements

  • Define, manage and maintain a documentation control system for all site cGMP Documents
  • Manage, index and control the on-site and off-site archive to meet cGMP needs.
  • Create and maintain procedures on site for Documentation Record Control & Retention and Architecture, Format & Content.
  • Train all site personnel on the Documentation Management Processes.
  • Conduct all activities in a safe manner and report all safety issues and/or concerns
  • Attends team meetings, regular 1:1's, support owns goals and team goals and actively manages own performance development.
  • Define, manage and maintain key metrics for Site Documentation ensuring site visibility, strong internal customer satisfaction and trending to support continuous improvement activities

Compliance Related Tasks

  • Ensure issuance and storage of documents
  • Participate in internal audits, support all external audits and any key quality initiatives
  • Support and report right first time documentation findings to support continuous improvement initiatives
  • Ensure continued site wide compliance with the documentation control process
  • Supporting and providing appropriate information to support Product Performance Reviews (PPR)
  • Ensure compliance to cGMP at all times

Qualifications:

  • Leaving Certificate or equivalent and will preferably have secretarial and/or clerical qualification or accreditation
  • Third level qualification (science or related discipline would be an advantage)

Experience

  • Minimum of 2 years' experience in a similar role

Skills & Knowledge

  • Very good knowledge of cGMP in a regulated environment
  • Excellent accuracy and attention to detail
  • Strong Planning/Organising skill
  • Customer Focus Driven with excellent interpersonal skills
  • Good Presentation skills
  • Working knowledge of computer systems
  • Personal development and goal management skills
  • Project Management skills and experience a distinct advantage

PLEASE NOTE: Candidates must have full working rights in Ireland i.e. (a current Stamp 4 Visa or an EU Passport to be eligible to work in Ireland) to be considered for this role.