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 within a pharmaceutical company, focusing on ensuring compliance and operational readiness for clinical trial materials. The expert will represent global IMP Delivery during internal and external audits and inspections, communicating directly with authorities and auditors. Key responsibilities include maintaining up-to-date supply chain information, processes, and SOPs to support audit readiness. The position also involves analyzing temperature deviations in investigational medicinal product (IMP) logistics, meticulously documenting deviations and complaints, and managing CAPAs within the company's quality system. This is an exciting opportunity for a professional with a strong background in GMP regulations and quality management to contribute to a growing international pharmaceutical environment, ensuring robust quality and compliance frameworks.
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
- Several years of practical experience in a GMP-regulated environment, ideally in clinical investigational medicinal products (IMP)
- Experience in quality management, particularly with deviations, CAPAs, and documentation in electronic quality systems
- Proficient in handling internal and external audits and inspections, including communication with authorities and auditors
Languages
Additional
- Temporary position for 18 months with option for extension
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