Computer System Validation Specialist
hace 2 semanas
Job Description:
Kymos Group, a leading analytical services provider for the pharmaceutical industry, is seeking a highly skilled professional to join our team as a Computer System Validation Specialist.
The ideal candidate will possess a strong background in computer system validation, with a focus on ensuring compliance with cGMP and GLP regulations. This role involves establishing compliance levels, participating in deployment and post-installation processes, and drafting documentation in accordance with regulatory requirements.
Key Responsibilities:
- Ensure compliance with computer system validation tasks, including data integrity and regulatory requirements.
- Draft documentation for computerized systems validation, adhering to cGMP and GLP regulations.
- Develop and maintain test plans, test scripts, and user acceptance tests.
- Manage changes in computerized systems, collaborating with Quality Assurance and IT departments.
- Carry out periodic reviews of computerized systems and maintain support software.
- Assist Quality Assurance during client audits and regulatory inspections.
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