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Sean McCarthy
Life Science

+3530212339371
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Details

Change Control SME


Reference:SMC839543 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Channel Manager

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

  • Technical support of vaccine drug substance and/or drug product processes to EP, including but not limited to person-in-plant support, directly within the EP manufacturing facility
  • Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
  • Collaborate across multiple technical functions within the organisation and the EP team to ensure the successful support and commercial manufacture
  • Author process change control documentation, technical communications, and process risk management.
  • Provides technical oversight, management, and planning support for complex partnership models.
  • Provides technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
  • Leads team for identification and assessment of partner risks and develops mitigations plans.
  • Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
  • Support/Coordinate/Manage investigations, with appropriate interface with other impacted manufacturing sites
  • Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.

Education & Experience
  • A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
  • Experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required
  • Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.