Head of Validation

Primary Job Objective

1. Management and implementation of qualification and validation activities at WTST, to ensure GMP compliance according to EU and FDA regulations, WuXi Biologics standards, and WTST internal SOPs.
2. Manage the PEV department during wide range of commissioning, qualification and validation activities.
3. Manage the PEV department to maintain the qualified and validated state of the equipment and systems.
4. Manage commissioning, qualification and validation activities from new projects.

Minimum Requirements

Education Background and Experience

1. Science / Engineering related educational background.
2. Over 5 10 years of experience in Commissioning, Qualification, Validation roles.
3. Demonstration of team management in past jobs.

Job Responsibilities

1. Review and approval of validation and qualification documentation and associated documents including Risk Assessment, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Shipping Validation, Cleaning Validation and Computerized Software validation and associated specification documents.
2. Evaluate and approve deviations related to validation protocols to guarantee appropriate documentation of the incidents and identification of corrective actions.
3. Coach the members from the PEV department and external contractors.
4. Represent the validation team on project/site core teams.
5. Provide quality guidance in accordance with current regulation and guidelines.
6. Review and approval of periodic reviews to demonstrate accurate validation state of process, facilities, utilities, and system ensuring compliance to procedures and regulatory requirements.
7. Provide support in quality-related issues, including GMP regulation, compliance with internal SOPs, aspects of safety and consistent operation of system.
8. Planning and leading qualification, validation, re-qualification and periodic review activities.
9. Collaborating with various departments (ENG/MFG/QC/SCM/MSAT/AIS/QA/Global teams/External Contractors) to complete qualification, validation activities.
10. Review and approval of qualification plans, protocols and reports in line with the project and internal PEV department timelines.
11. Review and approval of risk assessments and providing feedback to qualification related documents such as URS.
12. Oversighting planning and execution of equipment and system qualifications, as well as sanitisation, cleaning, shipping and process validation in cooperation with system/process owners, contractors and suppliers.
13. Oversighting implementation of Computerized Systems Validation (CSV).
14. Preparation and updating SOPs for qualification and validation, based on internal and external regulations and standards.
15. Performing and supporting problem solving and project improvements.
16. Performing and supporting change management, deviation management and CAPA management in a timely manner.
17. Ensuring that allocated trainings are completed on time.
18. Keeping up to date with current GMP regulations and industry practices.
19. Ability to adequately communicate in writing/orally to all levels of the organization on planning/progress of qualification and validation related activities.
20. Following Environmental Health and Safety guidelines set by the site and WuXi organization. Performing activities as per risk assessments where required.
21. Oversighting planning, execution and reporting of CSV activities in line with departmental and project timelines.
22. Review and approving of the CSV activities according to SOPs.
23. Review and approving CSV related gap assessments and risk assessments.
24. Where required performing resource planning and external CSV resource management.
25. Training relevant departments (ENG/MFG/QC/SCM/MSAT/AIS/QA/Global teams/External Contractors) on CSV principals and CSV SOP.
26. Supporting client projects from tech transfer to end of PPQ.
27. Support the audit from both internal and external regarding qualification and validation associated topics.