Business Development & Continuity Specialist | Business Development & Continuity Specialist (m/w/d), hybrides Arbeitsmodell
siecon personalmanagement GmbH
Job Summary
This role involves ensuring the continuity and compliance of global investigational medicinal product (IMP) delivery within a leading pharmaceutical company. The specialist will represent the IMP delivery team during 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 ensure audit readiness. The position also requires analyzing temperature deviations in IMP logistics, initial assessment and documentation of deviations and complaints, and timely reporting and processing of deviations and CAPAs within the company's quality system. Managing the audit and inspection calendar and reporting risk status to leadership are also crucial aspects of this role, demanding strong quality management and communication skills.
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 handling of internal and external audits and inspections, including communication with authorities and auditors
Languages
Additional
- Not specified
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