Senior Quality Officer - Engineering

Description

JobtitleSenior Quality Officer
DepartmentQuality Biotech
LocationNetherlands
PeriodASAP -

Department
Quality Biotech holds Quality Assurance oversight of the departments involved in the Biotech production process. Quality Biotech`s mission is to achieve local and global quality and compliance excellence within the processes that ensure patient safety. They ensure that the Biotech department is working according GMP procedures.
A sub department of Quality Biotech is Quality Systems & Improvement. They are looking for a temp hire which main task will be to coach, guide and enthusiasm staff to harmonize and implement new guidelines and structure of the QMS (Quality Management System). Within the sub department 9 professionals.

Job description
The Senior Quality Officer is responsible for:
Assist the Quality Systems & Improvement department with implementation of the QMS to integrate the client QMS requirements and structure into the local QMS, in parallel with preparation towards lean-QMS. He or she is responsible for the technical and/or utilities part.
Pro-actively assist Sub-System Owners within the organization to harmonize local instructions with global requirements and facilitate and guide QMS restructuring.
Job requirements
-HBO+/Academic level with engineering background (HTS) is a must;
-At least 3 years experience in a Quality Systems position within (preferably) the pharmaceutical industry;
-Experience with Project - and Change Management;
-Good knowledge and experience with Quality Management System development and governance;
-Good knowledge and proven experience with SOP Management;
-Good knowledge of GMP and ICH Guidelines (ICH Q);
-Well developed skills in Microsoft Word and Visio;
-Good written and oral communication skills (both in English and Dutch).

Skills & Competences
-Innovative;
-Creative;
-Pro active;
-Self starting;
-Teamplayer;
-Good communications and negotiating skills;
-Advice giving skills.