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GLP Auditor / Data Reviewer (m/f/d)
Adryan · Bâle
Description du poste
About the role
Adryan is seeking a quality‑oriented GLP Auditor / Data Reviewer to ensure scientific raw data and paper‑based study documentation meet Good Laboratory Practice standards. The role acts as a bridge between the operational laboratory, study departments, and Quality Assurance, guaranteeing data integrity before regulatory submission.
Key responsibilities
- Review paper‑based study documentation, raw data, and laboratory records for completeness, consistency, and GLP compliance.
- Reconcile data from internal databases with original paper records.
- Identify, document, and track deviations, discrepancies, or missing information.
- Conduct data reviews following internal QA processes and GLP requirements.
- Assist with internal audits and inspections.
- Create and maintain audit‑trail documentation, review reports, and quality records.
- Collaborate with study directors, scientists, and operational teams to resolve data‑related issues.
- Ensure overall data integrity throughout the study lifecycle.
Required profile
- Degree or vocational training in natural sciences, chemistry, biology, pharmacy, quality management, or a comparable field.
- Familiarity with the Swiss Ordinance on Good Laboratory Practice (2005) and OECD GLP guidelines.
- Initial professional experience in a regulated environment (GLP, GMP, GCP) is a plus.
- Strong attention to detail, structured work approach, and high quality awareness.
- Fluent in German and English.
Required skills
- Good knowledge of GLP requirements and regulatory documentation standards.
- Experience reviewing data, documentation, or quality records.
- Proficiency with MS Office, especially Excel and Word.
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Adryan
Bâle
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