Senior CSV Specialist
vor 3 Wochen
Our client, a leading international biopharmaceutical company, is seeking a highly skilled professional to join their team as a CSV Specialist. The ideal candidate will have a strong background in Computer System Validation (CSV) and experience working in the pharmaceutical industry.
The successful candidate will be responsible for ensuring the integrity of computer systems and processes within the company's regulated environment. This will involve designing, implementing, and validating systems to meet GMP requirements, as well as collaborating with cross-functional teams to ensure compliance.
The ideal candidate will have a strong understanding of GAMP 3 and 4, as well as experience with change management tools and regulated document authoring. Fluency in French and English is mandatory, and the ability to work independently with minimal supervision is essential.
We are looking for a highly motivated and detail-oriented individual who is passionate about ensuring the highest level of quality and compliance in the pharmaceutical industry.
Key Responsibilities:
- Design and implement computer systems and processes to meet GMP requirements
- Validate systems to ensure data integrity and compliance
- Collaborate with cross-functional teams to ensure compliance and quality
- Develop and implement change management plans
- Ensure compliance with regulatory requirements, including 21-CFR Part 11 and Eudralex
Requirements:
- 5-10 years' experience in IT, with a strong background in CSV and GAMP 3 and 4
- Experience working in the pharmaceutical industry, with a strong understanding of GMP requirements
- Fluency in French and English
- Strong understanding of change management tools and regulated document authoring
- Ability to work independently with minimal supervision
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