Validation Senior Manager / Associate Director

Summary

Subject Matter Expert in cleaning validation and SIP validation lifecycle, from design requirement analysis to retirement for drug substance and drug product manufacturing.

Job Responsibilities Role & Responsibilities

General:

1. Serve as SME for Cleaning Validation and SIP Validation for the Singapore facilities for Drug Product and Drug Substance
2. Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements

C&Q (Singapore Facilities Start-up):

1. Develop validation SOPs and C&Q deliverables for project start-up and operation readiness
2. Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders
3. Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required
4. Attend equipment FAT/training as required
5. Track the C&Q deliverables and ensure adherence to schedule from project to operation readiness
6. Lead resolution of validation variance / issues in a timely and compliant manner
7. Perform lesson learnt to share experiences and implement best practices;
8. Provide training and guidance on SOP and skills to team including vendors

CQV (Singapore Facilities Operation):

1. Maintain and track qualification status of site through periodic review, re-qualification and continue process verification programs and change control system
2. Serve as Cleaning Validation and SIP Validation SME to support the site in audit/visit by clients and regulatory authorities
3. Manage and coordinate Cleaning Validation and SIP Validation activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown
4. Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics

Qualification

Education

1. Bachelor degree or above in Engineering or Science discipline.

Experience

1. Demonstrated experience in validation or QA related work experience in cGMP environment (8 years as a guide)
2. Demonstrated experience in start-up facilities us preferred.
3. Demonstrated experience working in pharmaceuticals facilities in SG, EU or US.
4. Demonstrated experience in audits by EMA, FDA and other international authorities
5. Demonstrated experience in managing projects and team management is preferred.
6. Familiar with pharmaceutical CIP, COP and SIP processes in drug substance and drug product.
7. Demonstrated experience in VHP decontamination, Steam-In-Place and Depyrogenation processes is preferred.

Skills

1. In depth knowledge and experience of regulatory requirements and industry standards;
2. Project management skills;
3. Good understanding of Quality System, EHS.
4. Strong collaboration, self-motivation, communication, problem-solving and technical writing skills
5. Demonstrated knowledge of pharmaceutical technology and processes