CSV Consultant
We are seeking a versatile Computerized System Validation (CSV) Consultant to support one of our clients in validating computerized systems in a regulated environment. The consultant will be involved in critical projects ensuring compliance of computerized systems (MES, SCADA, LIMS, ELN, etc.). The contract duration would be set for an initial 6 months, with extension possibilities.
Responsibilities:
- Develop and execute validation plans for computerized systems in accordance with regulatory requirements.
- Write and review validation protocols (IQ, OQ, PQ) and validation reports.
- Ensure computerized systems comply with regulatory standards and Good Manufacturing Practices (GMP).
- Collaborate with project teams to ensure systems are properly validated and maintained.
- Participate in internal and external audits as a CSV subject matter expert.
- Manage validation procedures and regulatory requirements.
- Manage and validate computerized systems (MES, SCADA, LIMS, ELN, etc.) to ensure compliance and efficiency.
Qualifications:
- Degree in Computer Science, Engineering, Life Sciences, or a related field.
- 5 years of experience in computerized system validation in a regulated environment.
- Experience in Commissioning, Qualification, and Validation (CQV).
- Knowledge of validation best practices (e.g., GAMP 5, 21 CFR Part 11).
- Ability to work independently and as part of a team
- Versatility and ability to manage multiple projects simultaneously.
- Fluent in German and English (spoken and written).
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