Validation Engineer CSV
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- Contracting Our client, an international company operating in a GMP-regulated pharmaceutical environment, is looking for a Validation Engineer with experience in the validation of software packages and computerized systems. In this role, you will be responsible for the development, implementation, and execution of validation activities for cGMP-critical computerized systems, ensuring compliance with user, quality, and regulatory requirements.
Key Responsibilities
- Develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities.
- Develop, implement, and execute validation studies for cGMP-critical computerized systems to ensure compliance with cGMP, user, and regulatory requirements.
- Perform hands-on validation activities as required.
- Prepare validation documentation, including protocols and reports, and support protocol execution for computerized systems.
- Manage validation documentation through approval and implementation.
- Perform validation activities for computerized systems in accordance with applicable cGMP, cGLP, and internal procedures.
- Ensure computerized systems maintain their validated status at all times.
- Ensure projects are executed in line with applicable regulatory standards and internal quality requirements.
- Keep up to date with evolving validation regulations and testing practices.
- Provide technical support regarding current US FDA and EU validation requirements.
- Contribute to change assessments to evaluate the impact on validated status and validation documentation.
- Investigate and troubleshoot validation-related issues. Profile
- Minimum 3 years of experience in the pharmaceutical industry within a GMP-regulated environment.
- Experience with validation projects involving software packages and computerized systems.
- Good knowledge of Computer Systems Validation (CSV).
- Solid understanding of relevant quality and compliance regulations.
- Strong troubleshooting and problem-solving skills related to validation activities.
- Excellent communication skills.
- Ability to work independently and learn quickly.
- Ability to execute projects according to agreed plans and timelines.
- Good command of English and Dutch.
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