Beschreibung
Production Transfer (m/f/d)
Reference: -en
Start: asap
Duration: 18 MM
Main tasks:
- Responsible for technical management of commercial production for a defined portfolio of pharmaceutical products and CMOs
- Maintain technical product expertise and ensure GMP and regulatory compliance at CMOs
- Collaborative resolution of technical issues encountered at CMOs to support product supply and execution of IQ/OQ/PQ/MQ protocols, site level tech transfer, and continuous improvement activities at CMOs
- Support of day-to-day manufacturing operations at CMOs and resolution of issues (e.g. deviations, investigations)
- Technical visits at CMOs and participation in audits and inspections and Technical transfers and GMP qualification/validation activities incl. approval of documents
- Cooperation with Regulatory Affairs regarding Change Control, Notifications, Renewals of Registrations
- Writing and compilation of CMC documents including processing of the CMC Module 3 Document Sections for products in scope
- Legalization of GMP- and Manufacturing Authorizations and cooperation with Quality group regarding QA issues (e.g. complaints, deviations, OOS/OOT)
- Support process optimization and improvement activities within department and towards the CMOs
- Ensure launch of existing products in new markets and participate in launch of new in-licensed products
- Support interdisciplinary working/reporting and interdepartmental cooperation
- Technical input for quality and supply agreements, CDAs and Start-up agreements
- Applied Risk Management and Project and Alliance Management
- Product binder compilation and maintenance as well as Coordination of stability studies
Main qualifications
- Degree in Pharmacy, Chemistry, Biology, Process Engineering or equivalent
- Profound experience in project management, production, QA and/or QC within the pharmaceutical industry
- Good knowledge of regulatory requirements regarding manufacture of medicinal products
- Knowledge of relevant manufacturing processes and technologies
- General understanding of pharmaceutical business (incl. technical pharmaceutical knowledge, regulatory, legal and commercial aspects)
- Experience/knowledge about GMP regulations and requirements
- Experience in collaboration with contract manufacturing organizations
- Ability to solve complex situations and problems in a results-oriented manner
- Good collaboration and communication skills, team player
- Proactive, capable of efficient planning and prioritization of relevant tasks
- Cultural awareness: ability to build good relationships across cultures internally and externally, nationally and internationally
- Fluency in verbal and written English
Main advantages:
- Long term project
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Matthias Gabriel
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