Expert II, (Computer System Validation), Quality (Modulus Singapore)
Job Description
About the Job\n\nWe deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.\n\nSanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus Facility. The Modulus Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges as well as Specialty Care Biologics products.
One of these two Modulus facilities is constructed in Singapore at a new Greenfield site, with a design identical to the one in Neuville (France). The facilities will also have highly digitalized and automated capabilities which is a key enabler for operations using technologies such as autonomous guided vehicles (AGVs), cobots and cloud systems.\n\nAs an Expert II, (Computerized Systems Validation) QA you are to ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with Sanofi’s quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (i.e., from design to retirement) of computerized systems such as Computerized Information Systems (e.g., environmental monitoring system [EMS], laboratory information management system [LIMS], batch record management systems [MES], Data Historian), Process Control Systems (e.g., distributed control system [DCS], programmable logic controller [PLC]), Digital Infrastructure, Computerized Process Equipment, Laboratory Computerized Systems, and other integrated systems.
You will support the establishment and maintenance of site’s computerized systems validation program. You will also be responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented.\n\nKey Accountabilities\nResponsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet Sanofi’s quality requirements and fulfil regulatory expectations.\n\nCollaborate with cross-functional teams, including IT, Automation, and Manufacturing, in defining and implementing risk-based validation strategy to demonstrate the computerized systems are fit for intended use throughout entire life cycle, and to ensure that computerized systems are qualified and maintained accordingly.\n\nLead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, Sanofi standards, and industry practices.\n\nFunction as a key quality reviewer and approver of CSV lifecycle documents, including user requirements/functional specifications, validation plans, risk assessments (e.g., system criticality assessment, functional risks assessment, data integrity risk assessments), protocols, and reports.\n\nAuthor CSV plans and procedures.\n\nCoordinate and provide oversight for the documentation and maintenance of computerized systems inventory.\n\nEnsure continual improvement of CSV program by performing periodic review of the program.\n\nReview, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions.\n\nEnsure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use.\n\nProvide support during regulatory inspections and site audits as quality oversight and SME of CSV.\n\nPartner and collaborate closely with cross functional teams to achieve site’s GMP/operational readiness goals/objectives and ensuring all project deliverables are met on time.\n\nAbout You\n\nEducation and experience\nBachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields.\n\nA minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry.\n\nKey technical competencies and soft skills:\nSound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP requirements, and industry best practices (e.g., ISO, ISPE, PDA) pertaining to CSV.\n\nWorking knowledge of quality risk management methods and tools, including Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), and their application to the validation of computerized systems.\n\nSolid technical knowledge in the use and application of risk- and science-based approaches to CSV.\n\nDriven team player with the ability to collaborate and work with cross-functional teams (including global partners) to meet project timelines.\n\nGood communication skills to present validation strategies to the site management and other functions.\n\nExperience in greenfield/brownfield facility start-ups will be advantageous .\n\nFamiliar with Digital 4.0 concepts and potential applications in Quality.\n\nAble to work independently with little supervision.\n\nExperience with ensuring Data Integrity in computerized systems.\n\nnull