Adryan Deutschlandweit vor 2 Wochen

GLP Auditor

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ppAdryan is an internationally operating services group with offices in The Netherlands and Switzerland. Our teams work with top clients in the life sciences sector, ensuring the highest quality and commitment. /ph3Position Summary /h3pWe are seeking a quality-oriented GLP Auditor / Data Reviewer (m/f/d).

You will ensure that all data is documented in a complete, consistent, traceable, and regulatory-compliant manner before it is incorporated into reports and regulatory submissions. /ph3Main Responsibilities /h3ulliReviewing paper-based study documentation, raw data, laboratory records, and related documents for completeness, consistency, and GLP compliance /liliReconciling data from internal databases with the corresponding original documents (paper records) /liliIdentifying, documenting, and tracking deviations, discrepancies, or missing information /liliConducting data reviews in accordance with internal QA processes and GLP requirements /liliAssisting with internal audits and inspections /liliCreating and maintaining audit trail documentation, review reports, and quality records /liliWorking closely with study directors, scientists, and operational teams to resolve data-related issues /li /ulh3Requirements /h3ulliExperience on Swiss Ordinance on Good Laboratory Practice of 18 May 2005 and the relevant OECD GLP guidelines /liliQC/QA experience is also considered /liliDemonstrated proficiency in GLP audit procedures and documentation. /liliKnowledge of routine analytical methodologies, with an emphasis on chromatography /liliKnowledge of computerized system validation /liliGood interpersonal skills with demonstrable tact and diplomacy /liliGood computer skills including Microsoft Word and Excel.

Knowledge of MS-Access and SQL would be a plus /liliWith your openness and understanding of mutuality, your active communication and continuous value assessment you foster and encourage our team mentality.

We specialize in providing a full range of services for the life sciences industry, focusing on Project Management, Technical Operations, CQV, and Compliance.

In this role, you will be responsible for reviewing and verifying scientific raw data and paper-based study documentation in accordance with Good Laboratory Practice (GLP). /ppThis role serves as a central interface between the operational laboratory and study departments and Quality Assurance.

You communicate and work effectively with scientific staff at all levels within the Testing Facility and you see yourself as a creative problem solver. /liliGood oral and written communication skills in German and English /li /ul /p

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