Validation Senior Manager / Associate Director

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 :

• Serve as SME for Cleaning Validation and SIP Validation for the Singapore facilities for Drug Product and Drug Substance
• Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements
• Develop validation SOPs and C&Q deliverables for project start-up and operation readiness
• Plan, manage and coordinate C&Q activities with internal and external resources / stakeholders
• Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required
• Attend equipment FAT / training as required
• Track the C&Q deliverables and ensure adherence to schedule from project to operation readiness
• Lead resolution of validation variance / issues in a timely and compliant manner
• Perform lesson learnt to share experiences and implement best practices;
• Provide training and guidance on SOP and skills to team including vendors
• Maintain and track qualification status of site through periodic review, re-qualification and continue process verification programs and change control system
• Serve as Cleaning Validation and SIP Validation SME to support the site in audit / visit by clients and regulatory authorities
• Manage and coordinate Cleaning Validation and SIP Validation activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown
• Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics

Qualification

Education

Experience

Skills

Seniority level

Employment type

Job function

Industries

#J-18808-Ljbffr