Business Development & Continuity Expert | Business Development & Continuity Expert | M/W/D - Referenz 001004
consult16 GmbH
Job Summary
This role is for a Business Development & Continuity Expert at an internationally successful pharmaceutical company in Upper Swabia, Germany. The expert will be responsible for representing global IMP Delivery during internal and external audits and inspections, including communication with authorities. Key duties involve ensuring the availability of current supply chain information, processes, and SOPs for audit readiness, analyzing temperature deviations in investigational medicinal product logistics, and managing deviations and CAPAs within the company's quality system. The position also requires maintaining the audit and inspection calendar and reporting risk status to leadership. This is an excellent opportunity for a professional with a strong background in GMP regulations and quality management to contribute to critical operational continuity.
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, especially handling deviations, CAPAs, and documentation in electronic quality systems
- Proficient in managing internal and external audits and inspections, including communication with authorities and auditors
Languages
Additional
- Temporary contract for 18 months; Position is initially through temporary employment agency (ANÜ); Located in Upper Swabia, Germany
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