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Documentation Writer / Specialist QMS (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
305961/11
IHRE AUFGABEN:
-Participate in the development of a specific Quality Management System (QMS), actively implement the QMS documentation in cooperation with the various functions of the organisation
-Responsibility for ensuring that the quality requirements of the specific QMS are integrated into and addressed within the organisation and all newly defined and developed elements are integrated and introduced into the new QMS
-Write, update, review Quality documentation (standards, SOPs, WKIs) of Quality Management Systems in order to ensure compliance with GxPs and to other requirements defined by Regulatory department
-Support the organisation and actively participate in the implementation of external and internal guidelines and standards defined and/or selected by Regulatory department
-Act as key contributor with regard to the implementation and training of processes and quality documents owned, written and used by the organisation
IHRE QUALIFIKATIONEN:
-Substantial experience in environment with quality systems (ISO, GxP standards, FDA guidance, ICH guidelines) and preferably in the area of life sciences
-Excellent knowledge of Quality Management Systems and standards (FDA, GxP, ISO), very good knowledge of regulatory the environment
-General understanding of scientific issues (accomplished level)
-Excellent expertise in writing Quality documentations (standards, SOPs, WKIs)
-Excellent written and communication skills in English
WEITERE QUALIFIKATIONEN:
Quality management employee
305961/11
IHRE AUFGABEN:
-Participate in the development of a specific Quality Management System (QMS), actively implement the QMS documentation in cooperation with the various functions of the organisation
-Responsibility for ensuring that the quality requirements of the specific QMS are integrated into and addressed within the organisation and all newly defined and developed elements are integrated and introduced into the new QMS
-Write, update, review Quality documentation (standards, SOPs, WKIs) of Quality Management Systems in order to ensure compliance with GxPs and to other requirements defined by Regulatory department
-Support the organisation and actively participate in the implementation of external and internal guidelines and standards defined and/or selected by Regulatory department
-Act as key contributor with regard to the implementation and training of processes and quality documents owned, written and used by the organisation
IHRE QUALIFIKATIONEN:
-Substantial experience in environment with quality systems (ISO, GxP standards, FDA guidance, ICH guidelines) and preferably in the area of life sciences
-Excellent knowledge of Quality Management Systems and standards (FDA, GxP, ISO), very good knowledge of regulatory the environment
-General understanding of scientific issues (accomplished level)
-Excellent expertise in writing Quality documentations (standards, SOPs, WKIs)
-Excellent written and communication skills in English
WEITERE QUALIFIKATIONEN:
Quality management employee
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges