Business Development & Continuity Expert Pharma | Business Development & Continuity Expert Pharma (m/w/d)
akut... Kompetente Lösungen GmbH
Job Summary
This role is for a Business Development & Continuity Expert in the pharmaceutical sector, focusing on ensuring compliance and operational excellence within the IMP (Investigational Medicinal Product) delivery chain. The expert will represent global IMP Delivery in internal and external audits and inspections, engaging directly with authorities and auditors. Key responsibilities include maintaining up-to-date supply chain information, processes, and SOPs to support audit readiness, analyzing temperature deviations in IMP logistics, and managing deviations and CAPAs within the quality system. The position also involves coordinating the audit and inspection calendar and reporting risk status to leadership. This is an exciting opportunity for a professional with strong GMP knowledge and quality management experience to contribute to a growing international pharmaceutical company, with a supportive team and opportunities for professional development.
Required Skills
Education
Master's degree in Natural Sciences or Engineering (e.g., Pharmacy, Biotechnology, Chemistry, Process Engineering) or Bachelor's degree with extensive professional experience
Experience
- Professional experience in a GMP-regulated environment, ideally with Investigational Medicinal Products (IMP)
- Experience in quality management, specifically with deviations, CAPAs, and documentation in electronic quality systems
- Experience handling audits and inspections, including communication with authorities and auditors
Languages
Additional
- This position is initially limited to 18 months, with an option for extension.
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