Specialist II, Quality Engineering & Validation (QEV)
Sanofi
- Singapore
- Permanent
- Full-time
- Provide quality oversight of CQV lifecycle (including design, qualification, and continued verification phases) activities, including FAT/SAT, IQ/OQ/PQ, and continued verification of (but not limited to) the following:
- Facilities, utilities, equipment
- Temperature-controlled chambers/storage areas
- Laboratory computerized equipment
- Computerized system
- Cleaning and disinfection
- Sterilization
- Manufacturing processes
- Shipping/transportation
- Review, evaluate, and approve CQV related non-conformities and changes, and support investigations and corrective actions.
- Function as a key quality reviewer and approver of CQV lifecycle documents, including user requirements specifications, validation plans, risk assessments, engineering drawings, protocols, and reports.
- Participate in system design/code reviews, ensuring the design meets the user requirements and quality standards.
- Support technical team in defining and establishing site’s validation maintenance program to ensure that the validated state of the systems is maintained.
- Liaise with CQV project team to ensure all deliverables are met on time.
- Ensure all qualification/validation are successfully concluded, all documentation completed, and all non-conformities are addressed, before the systems are released for GMP use.
- Participate and support in regulatory inspections and site audits as quality representative.
- Responsible for ensuring all CQV activities meet Sanofi’s quality requirements and fulfil regulatory expectations.
- Partner and collaborate closely with cross functional teams to achieve site’s operational readiness goals/objectives.
- Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.
- A minimum 5-7 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.
- Sound knowledge and understanding of regulatory requirements and industry best practices (e.g., ISO, ASTM, ISPE, PDA) pertaining to management of validation lifecycle.
- Working knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Fault Tree Analysis (FTA), and their application to validation of systems.
- Solid technical knowledge in the use and application of risk- and science-based approaches to validation.
- Strong interpersonal relationships to establish the partnerships necessary for the development of an engrained Quality culture.
- Driven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.
- Good communication skills to present validation strategies to the site management and other functions and during inspections.
- Experience in greenfield/brownfield facility start-ups will be advantageous.
- Familiar with Digital 4.0 concepts and potential applications in Quality.
- Able to work independently with little supervision.