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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.
IT Cork City Dublin Medical Device Quality Control Microbiology Laboratory Scientist Medical Affairs Quality Assurance Engineering Cork Quality Engineering Scientific PhD Sales and Marketing Connected Health Clinical Research Mayo Supply Chain Academic Limerick Biotechnology Packaging Engineer Academic Scientist Manufacturing Executive Biopharmaceutical Validation Engineer Sales and Marketing Pharma Sales Pharmaceutical Project Manager Allied Healthcare Product Development Engineer Life Science Supply Chain Diagnostics Chemistry
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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
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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