職位描述
Key accountabilities:·Responsible for generating and monitoring of VMP, and maintaining and improving of validation system ·Responsible for writing and reviewing the qualification protocols, reports, operation SOPs and GMP documentations in compliance with the requirement of EU, FDA and SFDA.·Perform the execution of qualifications, cleaning validation and maintenance of validation equipment. ·Responsible for validation annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning ·Support the activities of facility’s design, commissioning and qualification, and review the related documentations ·Assist internal and external audit, write response report and follow up the corrective actions to ensure the actions complete timely·Provide validation and SOP trainings.·Be accountable and demonstrate good working ethics, integrity, ownership and leadership.Scope of the job:·Complete all the qualification document, SOPs and GMP related documentation on a timely manner. ·Conduct the work assignments in compliance with cGMP regulations whenever applicable.·To communicate with and assist different group or department in a timely manner to fulfill the work assignment of high quality and efficiency.·Depending on the focus area and individual expertise, demonstrate the capability to fulfill the work assignment of high quality.·Be able to work in a team environment and to complete the work assignment by interacting closely with colleagues and by developing cooperative working relationships with other personnel inside the company.Core skills and education:BS or Master degree in pharmaceutical or engineering, at least three years work experience in validation area of pharmaceutical industry.
