Provide Quality oversight of validation protocols, documents and procedures for manufacturing equipment, utilities, automation, cleaning and sterilization validation. Work with Technical Operation Validation team to resolve any protocol discrepancies. Provide technical expertise, as required.
Support for Quality review/approval of commissioning documentation, validation protocols, reports and support records to ensure compliance with local procedures; ensure timely resolution of documentation, compliance, and quality system issues.
Support the development of validation execution strategies and timelines with validation management and project team for manufacturing equipment, utilities, automation, cleaning and sterilization validation.