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Consumables Process Supporter - Consumables/GmP/Compliance
Eingestellt von ITech Consult
Gesuchte Skills: Support, Natural, Client
Projektbeschreibung
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 (eg medical technology, biotechnology.
Languages:
-Fluent in English (Writternhence we well understand what it means to be professionally supported in your search for a new project and being employed.
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 (eg medical technology, biotechnology.
Languages:
-Fluent in English (Writternhence we well understand what it means to be professionally supported in your search for a new project and being employed.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges