CSV QA Expert

CSV QA Expert (Pharma/ Validation/ GAMP)Salary Up to $8,000 depending on experience Location : Tuas Industry : Pharmaceutical Be part of building a next-gen, digitalized manufacturing facility in Singapore using advanced tech like AGVs, cobots, and cloud-based systems. Job Summary To ensure that computerized systems used in manufacturing and quality control processes are validated in compliance with company’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. Support the establishment and maintenance of site’s computerized systems validation program. Responsible for ensuring that controls needed to ensure computerized systems perform as intended throughout their lifecycle have been identified and implemented. Key Accountabilities Responsible for ensuring all Computerized Systems Validation (CSV) lifecycle activities meet company’s quality requirements and fulfil regulatory expectations. Collaborate with cross-functional teams, including IT, Automation, and Manufacturing, to define and implement a risk-based validation strategy that confirms computerized systems meet intended requirements and function reliably throughout their entire lifecycle, ensuring they are properly qualified and maintained. Lead and provide quality oversight for establishing and maintaining site’s computerized systems validation program in accordance with current regulatory expectations, company standards, and industry practices. Function 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. Author CSV plans and procedures. Coordinate and provide oversight for the documentation and maintenance of computerized systems inventory. Ensure continual improvement of CSV program by performing periodic review of the program. Review, evaluate, and approve CSV related non-conformities and changes, and support investigations and corrective actions. Ensure all qualification/validation activities are successfully concluded, all documentation completed, and all non-conformities addressed, before the computerized systems are released for GMP use. Provide support during regulatory inspections and site audits as quality oversight and SME of CSV. Partner 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. Requirements Bachelor’s or Master’s degree in Pharmacy, Science, Engineering, or related Life Sciences or Technology fields. A minimum 7-10 years of relevant experience, preferably in Validation and/or Quality in the pharmaceutical or biotechnology industry. Sound 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. Working 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. Solid technical knowledge in the use and application of risk- and science-based approaches to CSV. 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. 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. Experience with ensuring Data Integrity in computerized systems. #J-18808-Ljbffr