KEY RESPONSIBILUTIES:
r 1. Supports the investigation and reporting of Product Technical complaints
r (PTC) originating in China mainland and Hong Kong according to the CSL global
r procedures. Ensures CAPAs resulting in PTC investigations are implemented.
r 2. Oversight and management for local distributors. Supports Logistics
r deviation investigations including deviations within CSL Supply chain and PTCs
r as required. Actions will include organizing SQuIPP review assessments, issuing
r notice to quarantine product and oversight of the end to end deviation process
r impacting the China mainland and Hong Kong markets.
r 3. Final administrative release of imported products or support local batch
r release enquiries for respective markets where applicable and associated
r processes. Including regularly checking of quality documents of lot release and
r communicate with IDCs for any issues in lot release. As Liaison with
r manufacturing site and batch release personnel for any request from HA as
r necessary.
r 4. Collaborates with Customer Service, Medical Information and Global
r Logistics Operations to promptly resolve customer inquiries relevant to product
r quality and possible temperature/storage concerns following release of product
r from supply chain.
r 5. Support affiliate recall, market withdrawal and/or field action actions and
r ensure they are completed and communicated to key stakeholders within the
r organization.
r 6. Supports investigation of reports of ｃｏｕｎｔerfeit product discovered in
r China mainland and Hong Kong markets. Liaise with required functions (e.g.
r Logistics, Customer Service) to provide batch number verification through
r electronic systems for customer complaints or inquiries as required.
r 7. Supports maintenance and management of Quality Agreements between local
r distributors. Also maintain Quality Agreements between Affiliate and all Sites
r of Manufactures.
r 8. Establish and maintain a GxP training program in China mainland and Hong
r Kong affiliates for functions requiring GxP training.
r 9. ｃｒｅａｔｅ and manage Quality Management system for Affiliate which includes
r Policies, SOPs and Work Instructions.
r 10. Review and evaluate new regulations or changes to local GMP/GDP/GSP
r Regulations and assesses impact to current business practices. Communicates
r requirements to impacted parties in a timely manner.
r 11. Produce documentation for global inspections when requested in a timely
r manner. Work with multiple groups to acquire the requested documentation as
r needed.
r ESSENTIAL CRITERIA:
r 1. Bachelor’s degree or above majored in Biology, Pharmacy, Microorganism,
r Medicine, or Chemistry in Pharmacy.
r 2. Requires minimum of 5 years’ experience as a GMP or GD(S)P quality or
r systems professional in pharmaceutical manufacturing of drug products, medical
r devices or related field. Experience with Hongkong market is desirable.
r Requires effective communication, collaborative and negotiation skills. Must be
r comforｔａｂｌｅ working in a global, matrix organization.
r 3. Highly fluent in Mandarin, Cantonese, and English (Written & spoken)
r 4. Well-developed planning, and time management skills
r 5. High level organizational and problem-solving skills
r 6. High level verbal and written communication skills within a cross cultural
r and functional environment