招聘人数：1-2人
到岗时间：不限
年龄要求：不限
婚况要求：婚姻状况
语言要求：
英语
-Responsible for validation and verification processes;
-Assure that the product development processes and the applicable documentation are executed according to the agreed Product specific Design and Development Plans;
-Authority to review quality documents related to the design assurance projects;
-Authority to review validation documentation;
-Validation coordination, monitoring and review;
-Developing validation procedures;
-Drafting and maintaining validation plans and requirements;
-Validation training;
-Validation reporting;
-Participating in client meetings, when acting as validation & quality responsible person for projects;
-Participate in projects related to design assurance;
-Documentation creation and training related to design assurance;
-Promote tidiness and good order at the working place;
-Other duties as assigned by supervisor.
Education:
Applicable technical or academic education;
Knowledge and skills:
-ISO 13485, ISO 15378, ISO2859, ISO3951 and regulatory requirements (incl. 94/42-EEC, 21CFR Part 820);
-Knowledge of GMP and GAMP;
-Plastics materials basics, the construction and technologies of injection moulding tools and automation;
-Implemented Quality Management System;
-Organizational ability;
-Attention to detail;
-Work as part of a team;
-English language skills;
-Ability to take initiative.
Experience
-Minimum 3 years’ experience of product development in contract manufacturing plastics industry with international customers.
-Minimum 2 years’ experience of process validation
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