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
Main Tasks & Responsibilities:
Quality Assurance (QA) – 75%
Develop qualification / validation related SOP,
Provide regulatory and procedure traing to colleagues invlovled in qualification / validation activities,
Provide qualification/validation quality/compliance support following the internal procedure,
The validation of processes for the production of products (reagents), methods and systems (incl. cleaning) is carried out together with the specialist departments in accordance with the specifications as well as being processed in due time and documented,
Facilitate deviation investigation through qualification/validation lifecycle,
All functional units are consulted with regard to qualification/validation queries and supported with the implementation,
Ensure system validated state is maintained through closely control and follow-up of periodic reviews.
Employee Leadership – 25%
Skilled in thinking interdisciplinary; creating confident and open relationships within all organizational levels, specifically within matrix organizations,
Set up his/her own goals and tasks after discussions with superior,
Deal with complex problems in diverse range of tasks and kinds of stakeholder,
Coach junior employee in qualification and validation,
Master the responsibility for the accomplishment of the business strategy and goals, moderate effects on
several departments or interests (customers, staff and environment)
Basic Requirements of the Job:
Understanding of the common processes in production as well as general business practices within the regulated field of diagnostics and/or pharmaceuticals.
Education& Qualifications:
University graduate in one of the following fields: pharmacy, (bio-)chemistry, (molecular)biology, food and/or biotechnology;
Experience:
Well experienced in the field of process equipment / utility (water system, HVAC etc.) / laboratory equipment qualification or process / cleaning / computerized system validation (6-10 yrs.) in pharmaceutical or diagnostic industry
Long-term experience and proven skills in coordination different parties under complicated environment
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