GMP Compliance Expert
1 week ago
Lead Validation Activities:
The successful candidate will lead validation activities across multiple projects and sites to ensure compliance with regulatory requirements.
Main Responsibilities:
- Develop and implement validation plans, strategies, and test protocols.
- Cordinate the implementation of validation, qualification, and commissioning.
- Collaborate with cross-functional teams to develop and maintain validation documents.
- Drive continuous improvement initiatives to enhance validation processes and documentation.
Requirements:
- A technical or scientific university education.
- Over 10 years of experience in the medical device or pharmaceutical industry, with extensive experience in validation management.
- A structured way of working and leadership skills are essential.
- Thoroughness and technical interest are also required.
- Good oral and written proficiency in English is necessary.
- Skill in the application of statistical tools and validation of computerized systems, including GAMP5.
Why Join Us:
We offer a dynamic work environment, competitive compensation package, and opportunities for professional growth and development.
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