Clinical Materials Coordinator

Clinical Materials Coordinator – GMP /SAP R3 / German / English / supply chain

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Clinical Materials Coordinator

Background
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 of Investigational Medical Products in accordance with international standards and regulatory requirements. Furthermore, the CMC is responsible for all tasks related to clinical demand planning of packaging material.

Tasks & 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 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
* Plan and procure packaging materials in SAP-systems
* Supplier Relation Management: Manage various drug product- and packaging material suppliers to the Clinical Supply Chain Organization, incl. creating suppliers performance transparency with KPIs and taking applicable actions for continuous improvements
* Support of warehouse in goods receipt questions
* Perform virtual goods receipts
* Request the sampling and sample shipment of drug product and packaging materials
* 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 on time QA-release or AFM („Authorization for Further Manufacturing“) of drug products and packaging materials
* 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
* 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
* GMP Deviation- and Change Management
* Actively support inspections
* Actively support the Lean Production System (LPS)
* Lead and participate in global / local projects to optimize Clinical Supply processes
* Write and update SOPs and other department documents that support daily business

Must haves:
* B.A. or B.S. degree with 2+ years work experience in the pharmaceutical, biopharmaceutical or related industry, or a Master’s Degree with 1+ years relevant experience, or an equivalent combination of education and experience
* Work experience in supply chain, life science, industrial engineering or equivalent for at least 2 years
* High cultural awareness and social competence required as a cooperation and communication in complex situations with different cultures and countries is part of the daily job
* Customer-focused, ability to create trustful relationships with business partners
* Well-developed teamwork, collaboration and negotiation skills to communicate clearly and professionally both verbally and in writing
* Sound knowledge of Google and Windows office applications
* Excellent English skills, ideally also German skills
– Work experience in a GMP environment is beneficial
– Knowledge of SAP R3, APO knowledge is beneficial

Reference No.: 921015SKN
Role: Clinical Materials Coordinator
Industry: Pharma
Location: Basel
Workload: 100%
Start: 01.03.2022
Duration: 12++
Deadline: 14.02.2022

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: +41 41 760 77 01.

About us:

ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.