職位描述
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職位職能:
??醫(yī)藥技術研發(fā)人員??
職位描述:
Job Purpose:
Guided by J&J, XJP new product development guidelines, and aligned with company strategic objectives under the leadership of NPI Manager, the holder of this position shall implement new product introduction plan of related products, ensuring quality of new products, carry out pilot batch for manufacturing preparation purpose and product investigation to ensure timely & smooth introduction of new products, and implement process validation and cleaning validation plan of related products, ensuring quality of products.
Major Responsibilities:
Make detailed action plans for specific product transfer and carry out the plans. For specific project, manages and supervises all subordinates and coordinate Xian Plant and Beijing office about NPI project and trouble shooting for technical issue.
Take in charge technical transfer for specific new product project. Coordinates related internal and external Depts. And ensure the timely completion of all NPI phases.
Prepare registration files for related product.
Clinical trial sample preparation & Pilot trial for specific product
Summarize and report the progress of related project. Summarize and report the progress of process validation and cleaning validation
Draft and revised related protocol and report for process validation and cleaning validation.
Responsible to establish the Product BOM and Routing; Carry out process validation and cleaning validation on master validation plan; trouble shooting for related technical issue.
Know all position-related requirements for environmental, safety and industry hygiene, and comply with all these requirements.
Requirements:
Bachelor or above degree on pharmacy, chemistry, biochemistry and other related majors. Mater degree is preferred. Over 2 years working experience in pharmaceutical industry.
Fluent English in writing and speaking.
Good knowledge on pharmacy, GMP requirements & trends of local & international regulatory & statutory environment,production & quality processes.
Good interpersonal, communication and presentation skills.
Understanding of equipment, quality management, manipulation skill to pharmaceutical equipment and instrument.
Good Project management skills and problem solving ability.
