Regulatory Compliance Validator
3 days ago
Provide quality oversight for validation, qualification, and replacement of manufacturing process equipment.
Assess and approve acceptance tests, reports, and documentation in line with policies and compliance requirements.
Review and authorize engineering changes, deviations, and exceptions during validation activities.
Work closely with multidisciplinary teams to plan, coordinate, and execute validation procedures efficiently.
Maintain compliance with cGMP standards while ensuring adherence to site safety and security regulations.
Act as a liaison with stakeholders to ensure proper implementation of validation processes.
About You- At least 5 years of experience in equipment validation within a GMP-regulated environment.
- A Bachelor's degree in Engineering, Life Sciences, or a related field is preferred.
- Strong knowledge of cGMP standards and regulatory compliance for equipment validation.
- Experience in reviewing and approving validation protocols, deviations, and change requests.
- Ability to lead and coordinate validation activities across multiple projects.
- Excellent problem-solving skills and keen attention to detail.
- Strong interpersonal and communication skills to work effectively with cross-functional teams.
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