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 and packaging materials 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 companies' depots in accordance with international standards and regulatory requirements. Furthermore, the CMC is responsible for all tasks related to clinical demand planning of packaging material.
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:
* Single point of contact for global clinical supply related procurements of drug products and packaging materials. This contains the following responsibilities:
* Compile product-specific data and documents for drug products and packaging materials
* Define, request and continuously update the master data of drug products and packaging materials in SAP-systems
* Manage purchase orders for development drug products, "Partner" drug products, commercial drug products and external commercial drug products from internal and external suppliers in various systems
* Plan and procure packaging materials in SAP-systems for the PTDS packaging site in Kaiseraugst and stability studies
* Support the planning and procurement of packaging materials in SAP for the PTDS packaging site in SSF
* Request the sampling and sample shipment of drug product and packaging materials
* Initiate the system registration of packaging materials for QC testing
* Manage the compilation of a GMP- and customs-compliant goods receipt dossier for the QA-release of drug products and packaging materials
* Request and continuously update GMP- and non-GMP-batch data of drug products and packaging materials in SAP
* Ensure the QA-release or AFM ("Authorization for Further Manufacturing") of drug products and packaging materials on time
* Manage drug products and packaging materials returned to Kaiseraugst
* Manage the shelf-life extensions of packaging materials
* Confirm the quantities received to enable accurate cost charging of drug products and packaging materials in the relevant financial systems
* Actively support the cost allocation of drug products and packaging materials
* Drive and lead the issue management for global clinical supply concerning the procurement of drug products and packaging materials as well as the goods receipt of drug product
* Actively support GMP-, GCP- and BtM- (narcotic drugs) inspections
* Actively support the Lean Production System (LPS)
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
* German and English written and spoken
Nice to haves:
* Knowledge of SAP R3, APO knowledge is beneficial
* Work experience in a GMP environment
* 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: 12.04.2021
Duration: 12++
Deadline: 25.03.2021
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: .