You will manage Computer System Validation activities and system lifecycle, from design requirement analysis to retirement for drug substance and drug product manufacturing.
Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)
Job Responsibilities :
- Responsible for the qualification and validation of Computer System Validation for the Singapore facilities for Drug Product and Drug Substance
- Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements
C&Q (Singapore Facilities Start-up)
- 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
CQV (Singapore Facilities Operation)
- Maintain and track qualification status of site through periodic review, re-qualification programs and change control system
- Support the site in audit/visit by clients and regulatory authorities
- Manage and coordinate CQV 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
Requirement
- Bachelor degree or above, preferably in Engineering and Computer Science Discipline
- Demonstrated experience in validation or QA related work experience in cGMP environment (5 years as a guide)
- Demonstrated experience in start-up facilities is preferred.
- Demonstrated experience working in pharmaceuticals facilities in SG, EU or US.
- Demonstrated experience in audits by EMA, FDA and other international authorities is preferred
- Demonstrated experience with Computerized System Validation in drug substance and drug products (e.g. PLC, Delta V, SCADA, EMS, OT, Validation Lifecycle Management Systems, Temperature Mapping Systems)
- Demonstrated experience in implementation of enterprise business process systems is preferred.
- Good knowledge and experience of regulatory requirements and industry standards.
- Good understanding of Quality System, EHS.
- Strong collaboration, self-motivation, communication, problem-solving and technical writing skills
