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Commissioning and Qualification Lead - Fill Finish
| Reference: | SMC47569 | Location: |
Dublin |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
We’re currently recruiting for an exciting opportunity with a biopharmaceutical organization based in Dublin. 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
· Coordinates and Supervises all C&Q activities
· Approves C&Q planning documents detailing overall strategy for the project.
· Develops and approves the master list of C&Q test documents and activities.
· Reviews and Approves all C&Q summary reports.
· Ensures the C&Q schedule is developed and maintained.
· Ensures all C&Q Engineers who perform C&Q activities have relevant training assigned.
· Pre‐Approval and Post approval of C&Q test documents.
· Manages Daily C&Q coordination meetings.
· Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
· Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.
· Assist in the development of User Requirement Specifications (URS’s) and Quality
Risk Assessment for Equipment and Automated Systems (QRAES)
Education & Experience
· 6+ years experience in Engineering or Commissioning and Qualification Management
· Technical qualification at third level or equivalent in Engineering.
· Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology project
· Experience of sterile / biotech equipment within the pharmaceutical industry is preferred
· Knowledge of safety, GMP and environmental regulatory requirements.
· Strong understanding of a risk‐based approach to commissioning and qualification within the biotechnology industry
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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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