GMP Compliance Auditor (m/w/d) Pharma in Ludwigshafen am Rhein (1666)

Your career in pharmaceutical quality assurance.

In this challenging role, you will be responsible for ensuring regulatory compliance, conducting internal and external audits, and developing quality-relevant processes. You will work closely with QA leadership, suppliers, and departments to make a significant contribution to GMP compliance along the entire value chain.

Aufgaben

• GxP-Audits: Planning and independent execution of internal system audits as well as external GxP supplier audits.
• GMP-Konformität: Application and assurance of compliance with current GMP regulations for pharmaceutical products, medical devices, and regulated studies.
• Lieferantenmanagement: Maintenance of the approved supplier list, participation in the global audit plan, and support for relevant supplier processes.
• KPI: Collection, evaluation, and presentation of internal and external audit metrics for trend analysis for QA leadership.
• Compliance & Quality: Recommendation and follow-up on suitable measures to solve compliance and quality problems.
• Training & Support: Training and support of auditors and departments on GxP requirements; participation in authority and customer audits.
• Dokumentenmanagement: Development and maintenance of internal departmental systems, processes, and documentation as well as escalation of relevant compliance topics.

Qualifikation

• Qualifikation: Completed studies in Life Sciences or Engineering, alternatively a comparable qualification.
• Erfahrung: Professional experience in quality assurance, regulatory affairs, or the pharmaceutical/medical device industry.
• GMP-Expertise: In-depth understanding of international GMP regulations, experience in quality assurance audits desirable.
• Kompetenzen: Outstanding independence, analytical thinking, assertiveness, and strong technical and organizational skills.
• Zertifizierungen: Professional certifications like ASQ CQM or CQA are a plus.

Benefits

• Attraktive Konditionen: Look forward to an unlimited full-time position at BRÜGGEN ENGINEERING, with a salary that reflects your expertise.
• Qualitätsführerschaft: Take on a key role in GMP compliance within pharmaceutical quality assurance and make a significant contribution to ensuring the highest regulatory and quality standards.
• Dynamisches Team: Become part of a team that values personal growth and a culture of support and promotion.

We look forward to your comprehensive application with
specification of your earliest start date and salary expectations.

Your contact person for your application is:
Mr. Dipl.-W.-Ing. Thorsten Schermann

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