CSV Engineer Pharma
My client is an international pharmaceutical company located in South Holland. Their focus is on finding, developing, and producing a cure for various infectious diseases to help the sick affected by it.
In this role, you will be working as a CSV Engineer within the Quality Department. You will be providing technical expertise and guidance regards to computerized software validation. Assessing the GxP impact of any new application and delivering compliance validation plans and corresponding reports for the release of software to production will be part of your job as well.
- Give technical expertise and guidance with regards to the computerized system lifecycle and perform activities as needed.
- Independent quality review and approval of CSV deliverables and ongoing GxP related change controls.
- Provide Quality and CSV oversight to ensure compliance with applicable regulatory requirements and the companies policies and procedures throughout the system life cycle.
- Ensure change control procedures are followed to maintain the system including its software in a validated state throughout the life cycle.
- Implement controls to ensure data integrity and traceability of Quality records.
- Support process validations (IQ/OQ/PQ) and test method validation
- Identify critical areas for improvement and prioritize and execute the initiatives resulting from this. As needed, perform or support non-conformance / CAPA root cause investigations, defining action plans and driving these to completion.
- At least 5 years of relevant work experience, preferably in automated processes within the pharmaceutical or medical device industry.
- A relevant Bachelor degree
- Knowledge of and experience in Software Development Life Cycle processes, including: Requirements Definition (functional/ compliance/ non-functional), Design specifications, programming techniques, Risk based Testing approaches, and Risks and corresponding controls (software/ procedural).
- Working knowledge of computerized systems validation, validation of products/equipment/processes, statistics, risk management, change control, and data integrity.
- Familiar with implementing or applying Agile development processes.
- Good communication skills, including excellent command of the English language and preferably the Dutch language.
- Currently living in The Netherlands or a valid EU working permit