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Job Description
Job Description: Coordinate site validation program and ensure compliance with client policies, FDA, European cGMP and GAMP standards. Manage validation processes, create quality documents, and track equipment maintenance.
- Coordinate and participate in validation and quality assurance activities
- Generate and maintain site validation master plans, project validation plans, and validation protocols
- Implement corrective actions and manage change control processes
- Maintain and track validation equipment and document all activities
- Qualification in engineering or scientific discipline
- 3+ years of experience in cGMP, validation, and regulatory requirements
- Strong communication, presentation, and troubleshooting skills
- Effective interpersonal and organizational skills
- Able to prioritize work and multitask