acts as quality responsible person of celgene china and is herewith responsible for the gmp/gdp compliance and alignment of quality standards with celgene applicable policies.
ensures proper maintenance and implementation of celgene china quality management system: supervises correct drafting, issuing and storage of documents. establish and manage local standard operating procedures for relevant processes
responsible for ensuring continuous and initial training programs are implemented and maintained.
manages product quality complaints (pqcs), product returns & destruction and product recalls in accordance with celgene’s applicable procedures and gdps.
manages qa compliance activities at the affiliate in relation to deviations, capa, and change controls.
liaises with celgene logistics and oversees contract service providers to ensure gdp compliance of storage, transport and distribution activities as per technical and quality agreement in place.
responsible for preparing and hosting of internal corporate audits and gmp/gdp health authority inspections.
coordinate with the global compliance gxp audit (gmp/gdp, gpv, gcp) and inspection group.
responsible that self-inspection in china affiliate is performed regularly.
knows about the policy of security at work and about laws concerning health and security of the workers.
have oversight of quality activities for celgene marketing partner beigene
acts as quality responsible person of celgene china for pharmacovigilance in china affiliate and support pv team to maintain affiliate pv qms for pharmacovigilance activity in relation to sop management, training, deviations, capa, and change controls.
support clinical activities and celgene global cqa to meet gcp requirement if need.
ｃｒｅａｔｅs global mindset
promote open communication
the quality responsible person exercises direct technical supervision over trading operations in china. he/she ensures that the conditions of the wholesale dealer’s license are met, and the rules and guiｄｅｌines of good distribution practice are complied with. tasks may be ｄｅｌegated as appropriate to the deputy quality responsible person as well as other quality assurance persons.
the incumbent’s leadership will provide an environment that promotes and maintains a team-based collaborative culture.
required education: minimum of bachelor’s degree in life science or medically related field is required
more than 3 years manufacture site gmp qa experience or more than 3 years distributor gsp qa experience
excellent english writing & reading skills, fluent in chinese and spoken english
good interpersonal skills
good computer skills
the quality responsible person (rp) should have appropriate competence and experience as well as knowledge of and training in gdp:
legal recognition by the china health authorities as quality responsible person in the framework of [china drug law].
expert level of applicable regulatory requirements and enforcement.
strong identification with celgene’s values and general quality principles.
effective planning skills and recruitment skills to identify strong performers hire adequate members of staff and establish a high-performance organization; ability to anticipate resources needs and help establish priorities.