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Johnson & Johnson Ireland

Documentation and Change Control Specialist

Johnson & Johnson Ireland

  • Limerick
  • Not disclosed
  • Contract
  • Updated 08/08/2012
this job is expired
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Position Title: Documentation and Change Control Co-ordinator/Specialist Department: Quality Report to: C&Q Manager Location: Limerick (Fibron pad product) Position Summar...


Position Title: Documentation and Change Control Co-ordinator/Specialist
Department: Quality
Report to: C&Q Manager
Location: Limerick (Fibron pad product)
Position Summary:
Documentation and Change Control Coordinator within the Quality Department is responsible for the administration and coordination of the activities associated with the Document Management system, including  generation, execution and lifecycle Change control system.
Main duties and responsibilities:
·         Ownership of the Controlled and Standard Document Library, both paper based and managed with an industry standard automated system.
·         Distribution, tracking, maintaining and filing of all documents.
·         Administration of the Records Retention policy
·         Status reporting of metrics for the document lifecycle management process Responsible for the coordination of all staff  training requirements with respect to Document control Management of the Change Control process
·         Co-ordination and approval of Change packages before submission
·         Status reporting of the metrics for the Change Control system
·         This role will also include significant involvement in the management of Qualification documentation (eg.DQ/IQ/OQ) during the project phase
·         Working with the Quality team to generate weekly Document/Protocol Generation/Execution status reports.
Provide training where required on the document management and Change control systems

Education and Experience:
·         Minimum qualification Bsc or MSc/M.Eng Degree in one of the following disciplines:  Chemistry, Biochemistry, Biotechnology Biochemical or Chemical Engineering, Chemistry, or equivalent discipline
·         3 Years minimum post educational experience with working in a regulated  environment preferably within a Pharma/Biotech facility
·         Experience of coordination of Quality documentation and in particular, qualification/Validation documentation and using an electronic document management system.
·         Understanding/experience with a process and utility plant start-up would be an advantage
·         Good level of computer literacy required
Candidate Profile
The candidate should have a desire to join a dynamic and fast moving team with tight deadlines and to become a key resource within this team. He/she will be very organized and methodical in their approach and have an eye for detail. They should like handling paperwork but also be comfortable with electronic systems and have a high capability in the use  of computer programs such as Microsoft Office, Excel, Word etc. The candidate should possess a confidence and credibility that will enable them to establish a good professional relationship and influence with colleagues and senior management  The candidate will work closely with all members of the team and have the support of the team to fulfill their responsibilities.

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Ref: 000005Q7
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Johnson & Johnson Ireland

Johnson & Johnson Ireland

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