北京招聘

The incumbent is responsible for supporting activities relating to BeiGene’s China commercial QA which including importing product testing and COA management, complaint handling, documentation management, training, reagent/reference standard management, pharmacopoeia monitoring and other administrative work. The scope of the China Commercial QA covers China mainland, Hongkong, Macau and Taiwan. This incumbent will also support related GMP/GSP activities to support internal and external QA operations at the suppliers.
?Ensure the training for the work is in the place and all procedures are followed
?Focus on the management of authorized activities and the accuracy and quality of records
?Ensure that relevant customer complaints are dealt with effectively
?Ensure that suppliers and customers are approved
?Keep appropriate records of any delegated duties
?Decide on the final disposition of returned, rejected, recalled or falsified products
?Ensure that any additional requirements imposed on certain products by national legislation are adhered to
?Provide QA support to supply chain and logistics
?Support product release process including COA, temperature assessment and batch record
?Ownership of activities within electronic quality systems regarding deviations, temperature excursions, product complaints, change controls, investigations, and CAPAs and interfacing with internal team members and contract manufacturing and testing sites to progress activities within electronic quality systems
?Work with departmental key stake holders and internal staff to ensure processes and procedures remain in a compliant state
?Support internal network audit programs and manage supplier GMP audit programs
?Work with Global GMP Quality to prepare metrics. Coordinate metric analysis and quality adjustment to ensure continuous process improvement
?Provide QC review of product testing data and Health Authority submissions
?Provide Support with Health Authority and Business Partner audits
Core Competencies, Knowledge and Skill Requirements
?General knowledge of GMPs and GDP
?Experience with regulatory compliance inspections
?Good verbal, written and interpersonal communication skills.
Communication & Interpersonal Skills
?Good communication and English language skill l
?
Significant Contacts Interacts within QA organization and other functions like supply chain collaboration partners and vendors
职位要求：
3 year or above pharmaceutical or biotechnology industry GMP/GSP experience

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。