Beschreibung
Consumables Process Supporter - Consumables/GmP/Compliance/Risk Management/Pharma/ German.Role Purpose: Our client is looking for Consumables Process Supporter where he/she will be working in a team - coordinating interfaces - supporting product managers, stakeholders and suppliers - supplier contact - understanding, analysing and structuring complex interrelationships with good experience working in pharma/laboratory domain.
Tasks and Responsibilties:
-Responsible to contact person for compliance topics within the CoE Consumables
-Support in the maintenance / creation of quality-relevant documents for maintaining compliance according to clients Guidelines.
-Support and coordination of validation projects in close cooperation with the disciplines involved .
-Review of the entire validation documentation, including the quality management system - Review of the entire validation documentation in accordance with the clients guidelines Qualification, re-qualification and periodic review of valid processes
-Review and collaboration in the preparation of process risk analysis
-Responsible for supplier development in the area of validation.
-Responsible for ensuring GMP-compliant documentation.
-Responsible for contributing specialist expertise to projects filing and archiving documentation.
-Responsible for coordination of risk management activities within the CoE.
-Responsible for carrying out product risk analyses, maintenance of risk files in accordance with clients guidelines.
Must have requirements:
-Must have atleast 3 years of experience working with CoE Consumables.
-Good Experience/Knowledge working with ISO 13485.
-Good knowledge/experience working with GMP and compliance
-Must have atleast 3-5 years of professional experience in the regulated pharmaceutical or medical technology sector.
-Should know how to with basics of DIN EN ISO 14971 and FMEA preparation from risk management point of view.
Education:
-Bachelor of science with focus on technology or natural sciences (e.g. medical technology, biotechnology.
Languages:
-Fluent in English (Writtern & Oral).
-Fluent in German
Reference No.: 917521NC
Role: Consumables Process Supporter - Consumables/GmP/Compliance/Risk Management/Pharma/ German.
Domain: Pharma
Location: Luzern und region, Switzerland
Workload: 100%
Start Date:
Duration: Till
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: .
About us: ITech Consult is a certified ISO 9001:2008 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT 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.