Change Control Specialist

IE  ‐ Onsite
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Description

An exciting opportunity to be a Change Control Specialist within a Global Pharmaceutical company has arisen. This will be a 12-month initial contract based in Ireland.

Change Control activities include:

  • The position will involve progressing and reviewing change control documentation from all areas on site.
  • Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision.
  • When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, for the most efficient way of progressing proposed change with minimum disruption to the site.
  • Review change control documentation received for clarity, ensuring relevant supportive data has/will be generated.
  • Confirm categorisation of site change control
  • Establish productive working relationships with colleagues within project teams at site and other regulatory/change control subsidiaries.
  • Link in with site Change Owners in terms of what change control would need to be reviewed by CMC regulatory personnel to determine impact to clinical/commercial licenses for proposed changes.
  • Provide change control support as required during HA inspections
  • Provide change control training to the site for change originators and reviewers of proposed changes
  • Leverage off the network in terms of change control guidance and support for biologics and vaccines when required.
  • Provide guidance and support to the site in terms of change control business processes and systems
  • Support the application and management of site licenses and GMP certificates.
  • Update manufacturing authorization to ensure that site documentation is in line with approved registrations.
  • Carry out annual product reviews from Change Control Perspective
Qualifications Needed
  • Degree in Biological Sciences, Biochemical engineering or related discipline. Advanced degree preferred
Experience Needed
  • Minimum 3-5 years biological experience in Regulatory/Technical/QA in biological research, and/or a manufacturing environment
  • Project management skills
Start date
January 2018
Duration
12 months Initially
From
Quanta Consultancy Services
Published at
15.11.2017
Project ID:
1451803
Contract type
Freelance
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