As a Team Member – Validation, you will oversee the compliance of revalidation schedules across sterile injectables, spanning Manufacturing, Quality Control, and Development areas. Your role is pivotal in validating and revalidating facilities, utilities, equipment, and processes in strict accordance with regulatory guidelines.
Roles & Responsibilities:
- Ensure compliance with periodic revalidation schedules for facility, equipment, Media fill in Production, QC, and development areas.
- Develop and review Validation Master Documents (VMPs), validation plans, SOPs, and validation protocols in alignment with current Good Manufacturing Practices (cGMP), company standards, and regulatory requirements.
- Implement new systems and improvements related to validation processes in compliance with regulatory guidelines and manage change controls.
- Collaborate closely with engineers and vendors to ensure accurate information exchange and provision of qualification documentation.
- Support Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Qualification (VQ) activities.
- Assist in internal and external audits, develop Corrective and Preventive Actions (CAPAs), and ensure Quality Management System (QMS) compliance within the validation function.
