Operation Planning Expert (GMP – Drug Development and Manufacturing) – Lucerne/Schachen, Switzerland
Clintec currently has an exciting opportunity for an experienced Operations Planner (GMP) to join our team in Switzerland, working fully dedicated to one of our clients – a top 5 global pharma company at their biological drug development and manufacturing site located near Lucerne, Switzerland.
This is an excellent role for a candidate to join our growing, global and award-winning company on a full time and permanent basis.
The Operation Planning Experience will be responsible for coordinating packaging projects for the clinical supplies function. The successful candidate will provide support assigned projects from end-to-end including set up and coordination/monitoring throughout the assigned project to completion across the different work centres of the supply chain (label design/printing, packaging and QC).
Provide input and partner with other work centres to develop the packaging/labelling strategy for the individual clinical products
Monitor the adherence to project schedules and documents progress in respective databases
Assist the work centres (Global Project Management, Packaging, Label Operations, Quality disposition group) for issue resolution as needed
Collaborate with global master planning and project management (demand and supply project managers) to establish priorities across different projects
Negotiate timelines with contract manufacturers and requests/reviews quotes
Order multi‐language booklet labels from third party suppliers
Generate Master Data (Material Master, Bill of Material, Recipe)
Generate project specific master documents (e.g. Batch Record)
Generate and release process/print orders for production
Work out proposals for continuous optimization of processes & procedures (SOPs) concerning clinical supply planning and packaging operations
Main POC for the Clinical Supplies Demand Manager and the contract manufacturer
Comply with GMP regulations
Develop, implement, and continuously improve processes and associated SOPs based on International Regulatory Standards, company Quality Guidelines and GMP regulations
Follow workflows and procedures according to current SOPs
Respect company policies concerning health and safety, finance and quality
Educated to Bachelor/Master degree level in Engineering, Life Sciences or another closely related discipline
5+ years industry experience working within a pharmaceutical, biotechnology or medical device environment
Previous experience working within a GMP environment (familiar with requirements, quality procedures and SOPs)
Hands-on experience within any of the clinical supply areas: Planning, Scheduling, Coordination, Artwork and/or Label Translation
Project Management Skills
Flexibility and ability to work as part of a team
Diligent and quality orientated
Proven ability to organise workload and manage multiple tasks at once to meet deadlines
Fluent in English and German languages
Ability to work site based in Schachen
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.