Aktuelle Jobs im Zusammenhang mit Quality Associate – Computerized Systems Validation - Düsseldorf - Pharmiweb
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Computer System Validation Specialist
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Product Validation Specialist
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Product Validation Specialist
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Product Validation Specialist
Vor 3 Tagen
Düsseldorf, Nordrhein-Westfalen, Deutschland Mercedes-Benz VollzeitJob DescriptionMercedes-Benz AG is a leading automotive company with a strong focus on innovation and quality. We are seeking a highly motivated and skilled individual to join our Product and Process Assurance BR2 and 3 department within Mercedes-Benz VAN Engineering.Key ResponsibilitiesSupport employees in the digital methods task area, particularly in...
Quality Associate – Computerized Systems Validation
vor 3 Monaten
Quality Associate – Computerized Systems Validation (CSV)
Location: Germany (remote)
Start Date: ASAP (permanent position)
Competitive Compensation Package + Benefits
Are you driven by innovation and the quest for scientific excellence? Our client, a leading Clinical Research Organization in Germany, is searching for a highly motivated Quality Associate to execute a variety of CSV tasks in line with GCP standards. With full training and certification provided, this role offers an ambitious individual the opportunity to develop into a CSV expert.
What will you be doing?
- Manage computerized system validation projects for GxP relevant computerized systems.
- Ensure computerized systems used in GxP operations are validated for their intended use (Computerized Systems Validation – CSV).
- Support process and system owners in the following activities:
- Collecting, describing, and analyzing business requirements for IT systems (business analysis).
- Risk identification, risk assessment and risk mitigation.
- Planning, conduct and report of CSV activities.
- Performing periodic reviews of the validation status of systems.
- Conduct manual or automated tests on systems, or support SMEs in the conduct of manual tests.
- Improvement of internal systems for the planning, implementation, and documentation of CSV activities.
- Ensuring inspection readiness of all GxP relevant computerized systems.
- Support in the interface management with external partners and CROs, review of customer requirements and ensuring their fulfilment.
What do you bring to the table?
- Pharmaceutical industry experience in Quality Assurance or Computer System Validation.
- Good knowledge of good clinical practice (GCP).
- Strong Microsoft Office proficiency.
- Excellent communication skills.
- Fluent in English and German.
- Graduate degree.