Sr. Validation Manager- Switzerland- Contract
I am looking forward to speaking to talented and responsible Validation Specialists to join my client, a world leading Biotech that is going to offer a lot of professional development and learning opportunities, as well as opening future career doors.
You would be accountable for the laboratory instruments qualification, including Computer System Validation (CSV) in the QC laboratories and would also support the deployment of Data Integrity (DI) in the department, offering you cross functional responsibilities that are going to expand your network globally whilst learning from the best!
- 1. Manages all aspects of the Validation Department in accordance with current guidelines on equipment, utilities, and facilities validation, in compliance with pertinent regulations (e.g., FDA, EMA).
2. Assesses overall validation workload, staffs accordingly, and deploys resources to attain Manufacturing Engineering & Facilities (MEF) and production goals. Manages and tracks the execution of all relevant validation activities within the Manufacturing and Laboratory areas, integrating their time line with ongoing projects and programs.
3. Coordinates tracking of validation protocol execution status and ensures completion of validation projects per required schedules.
4. Interacts with people from all departments to resolve issues.
5. Manages a team of validation personnel, including training, developing, coaching, and addressing personnel issues.
6. Coordinates participation on Tech Transfer, and cross- functional teams including global Validation, CMC, start-up
7. Works to ensure Validation organisation receives the emphasis and resources required to achieve site and corporate goals.
8. Presents and defends validation systems to Regulatory Inspectors
- Practical knowledge and application of GMPs, GLPs, and EMEA and ISO regulation
- Experience dealing with FDA investigators, authoring responses to critical, major or minor observations and implementing corrective measures.
A minimum of 8 years related experience and/or training; or an equivalent combination of education and experience
*A minimum of 2 years experience in leading a team.
* Experience in coordinating / leading cross-site or cross-functional initiatives.
* Requires excellent oral and written communication skills.
If you are up for the challenge, send your profile across to Alex at firstname.lastname@example.org so he can give you more details about the role!
The job market changes very quickly so do not forget to connect with me on LinkedIn, check other roles that I am hiring for at the moment and follow for any future relevant roles.
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