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Details
Change Control SME
Reference: | SMC839543 | Location: |
Cork |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | 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.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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