Global LIMS Validation Manager
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Here is a great opportunity to join a rapidly expanding global biopharmaceutical company, who is dedicated to being leaders in innovative medicines and vaccines. The company is seeking a Global LIMS Validation Manager to join their team in Darmstadt, Germany.
Job Responsibilities:
- Define and establish the global validation approach for the LIMS system implementation
- Ensures GxP Compliance of the global LIMS system implementation
- Provide quality assurance and regulatory support
- Create and approve the Validation Plan as well as key validation deliverables
- Monitor the implementation of guidelines and procedures to ensure compliance
- Approve test activities, e.g., IT; UAT, MT tests
- Training the LIMS GKUs for creating validated documents, e.g. URS, RA, test cases
- Support data migration activities
- Manage and consult involved functions in the change request process; monitoring adherence to the process
- Ensure up to date validation documentation in the central system
Skills and Requirements:
- Deep Knowledge in quality processes and project approach
- Deep knowledge in Computer Validation Systems
- Demonstrated success implementing a validated quality system as Validation Manager
- Strong knowledge of cGMP
- Overall understanding of the process landscape within the different countries
- Good knowledge of LIMS system
- Fluent in English
- Willingness to travel (>50%)
- Management / leadership skills
- Excellent communication skills
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Badria Kahie on +44 203 8718 094 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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