Beschreibung
Clinical Materials Coordinator (m/w/d) - life science/ cGMPs / SAP /English /GermanProject:
For our customer a big pharmaceutical company situated in Kaiseraugst we are searching for a highly qualified Clinical Materials Coordinator (m/w/d)
The Clinical Materials Coordinator (CMC) leads the coordination and execution of all procurement activities of drug products for global clinical studies. This includes the coordination of the release of these materials to ensure a timely production and delivery of Investigational Medical Products to Roche depots in accordance with international standards and regulatory requirements.
Perfect candidate:
The ideal candidate has excellent written and oral communication and negotiation skills in German and English, is an open-minded, self-motivated, quick thinking, proactive, and customer-focused individual with work experience and knowledge of SAP.
Tasks & Responsibilities:
* Compile product-specific data and documents for drug products
* Define, request and continuously update the master data of drug products in SAP-systems
* Manage purchase orders for Roche development drug products, "Roche-Partner" drug products, Roche commercial drug products and external commercial drug products from internal and external suppliers in various systems
* Request the sampling and sample shipment of drug product
* Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products
* Request and continuously update GMP- and non-GMP-batch data of drug products in SAP
* Ensure the QA-release or AFM ("Authorization for Further Manufacturing") of drug products on time
* Manage drug products returned to Kaiseraugst
* Drive and lead the issue management for global clinical supply concerning the procurement of drug products as well as the goods receipt of drug products
* Actively support GMP-, GCP- and BtM- (narcotic drugs) inspections
* Actively support the Lean Production System (LPS)
Collaborations:
- Within the department:
* Clinical Demand and Supply Leader (CDSL) in Kaiseraugst and SSF
* Warehouse, packaging facility and technics group
* In Process Control (IPC)
* Master Data Team
* Clinical Supply Coordinator (CSC)
* Global Clinical Distribution Lead (GCDL) and Clinical Distribution Associate (CDA)
* Shelf-Life Management Team
* Training and Compliance
- Cross-functional:
* Procurement
* Pharmaceutical and analytical R&D functions
* Commercial Roche sites
* Commercial warehouse in Kaiseraugst
* PTM Development Europe
* Quality Assurance (internal and external), Quality control and EU QP's
* Global Strategic Resource and Portfolio Management (PTDS-R), Accounts Payable & Receivable, Management Accounting
* Medical Affairs (PDMA)
* Occupational Hygiene and Group Health Protection
* IRCI-Registration
* Global Packaging Material Development (gPKD)
* Local Packaging Development
* Supplier Quality Management (SQM)
* Device Development
* Direct Material Specification Lifecycle Team (DMSLT)
Must haves:
* Associate level of professional education or University degree preferably in Supply Chain Management and/or Healthcare Management
* Work experience in supply chain, life science, industrial engineering or equivalent
* High cultural awareness and social competence required as a cooperation and communication in complex situations with different cultures and countries (especially Northern American and Asian market) is part of the daily job
* Demonstrated excellent problem solving and decision making skills
* Experience with customer relationship management, ability to create trustful relationships with business partners (*****)
* Excellent German and English written and spoken
* SAP and GMP experience
Nice to haves:
* APO knowledge
* Sound knowledge of Google and Windows office applications
Personal requirements:
* Well-developed teamwork, collaboration and negotiation skills to communicate clearly and professionally both verbally and in writing
* Well organized, high level of planning skills
* Ability to work independently
* Self-motivated, proactive, quick thinking and adaptable
* Ability to set priorities and to remain flexible in stressful situations
* Well organized, high level of planning skills
Working time:
* flexible working times
Referenz Nr.: 920170SGR
Role:Clinical Materials Coordinator
Industry:Pharma
Location:Kaiseraugst
Workload: 100%
Start: 01.05.2021
Duration: 12++
Deadline: 13.04.2021
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .