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Details
Validation Lead
Reference: | AMC3472 | Location: |
Dublin South |
Qualification: | Degree | Experience: | See description |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Validation Manager
Validation Lead - Fill Finish
12 month contract
South Dublin
AMC3472
I am on the lookout for a Validation Lead for a large scale, Fill Finish project with one of my Biopharmaceutical clients. In this role you will lead a team of Validation engineers to ensure that a large fill finish project is a completed safely, on time and in compliance with GMP and Quality Requirements.
If you have a relevant degree along with 7+ years in Validation in the pharmaceutical and biopharmaceutical industry this could be the role for you!
Key responsibilities:
- Oversee and coordinate all validation activities.
- Approve validation planning documents outlining the overall project strategy.
- Develop and approve the master list of validation test documents and activities.
- Review and approve all Commissioning & Qualification (C&Q) summary reports and validation summary reports.
- Ensure the validation schedule is established and maintained.
- Verify that all validation engineers conducting validation activities have the necessary training.
- Manage the pre-approval and post-approval of validation test documents.
- Organize and lead validation coordination meetings.
- Track and report on validation status, including risks and issues.
- Assist in developing User Requirement Specifications (URS) and conducting Quality Risk Assessments for equipment and automated systems (QRAES).
Key requirements:
- Bachelor of Science or equivalent degree
- 7+ years experience gained in Validation, Engineering, Microbiology or Quality
- Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
- Sterile/Biotech equipment validation experience
- Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
- In-depth understanding and application of validation principles, concepts, practices, and standards.
- In-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
- Working knowledge of sterilization/decontamination systems and industry practices.
- Experience with AVS (Airflow Visualization) Studies.
- Experience of aseptic processing
If this sounds like you please apply today and I will be in touch with more info.
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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
Valid XHTML - CSS