09.10.2026 aktualisiert
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Quality and Compliance Consultant, CSV Engineer|
Mörfelden Walldorf, Deutschland
Deutschland
B.Sc. Chemical TechnologiesSkills
21 CfrSix SigmaAuditsAutomatisierungISO 9000ProzessoptimierungComplianceDokumentenmanagementRecords ManagementElektronische SignaturenFmeaLebensmittelvorschriftenIso 13485Lean ProzesseProjektmanagement
1. Quality Manager
Technical Skills:
2. CSV (Computer System Validation) Engineer
Technical Skills:
Technical Skills:
- Quality Management Systems (QMS): Expertise in ISO 9001, ISO 13485, and other relevant standards.
- Regulatory Compliance: Deep understanding of GMP, FDA regulations, EU MDR, and other industry-specific regulations.
- Auditing: Conducting internal and external audits, familiarity with audit techniques, and managing audit findings.
- Risk Management: Proficient in risk assessment techniques such as FMEA, HACCP, and root cause analysis.
- Process Improvement: Knowledge of Lean, Six Sigma, and Continuous Improvement methodologies.
- Document Control: Managing quality documentation, including SOPs, work instructions, and quality manuals.
- Communication: Strong verbal and written communication skills for interacting with stakeholders at all levels.
- Problem-Solving: Analytical mindset for troubleshooting and resolving quality issues.
- Attention to Detail: Meticulous approach to ensuring all aspects of quality are maintained.
- Project Management: Ability to manage multiple quality initiatives and projects simultaneously.
2. CSV (Computer System Validation) Engineer
Technical Skills:
- Validation Lifecycle: Proficiency in the entire CSV lifecycle, including planning, testing, and validation.
- GxP Compliance: Understanding of Good Automated Manufacturing Practice (GAMP) guidelines and how they apply to CSV.
- 21 CFR Part 11 Compliance: Knowledge of FDA regulations regarding electronic records and electronic signatures.
- Testing and Qualification: Experience in IQ/OQ/PQ (Installation Qualification, Operational Qualification, Performance Qualification) processes.
- Risk-Based Validation: Ability to apply risk management principles in the validation process.
- Software Development Life Cycle (SDLC): Familiarity with SDLC methodologies and how they integrate with CSV.
- Documentation: Strong skills in writing validation plans, protocols, and reports.
- Analytical Thinking: Ability to analyze systems and processes to identify validation needs.
- Attention to Detail: Ensuring all aspects of system validation are meticulously documented and compliant.
- Communication: Clear communication with stakeholders, including IT, QA, and regulatory bodies.
- Problem-Solving: Identifying issues during validation and providing solutions.
- Collaboration: Working effectively with cross-functional teams, including IT, quality assurance, and regulatory affairs.
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2023
Sprachen
DeutschMutterspracheEnglischverhandlungssicher