Senior QA Specialist 高级质量专员 - 北京

Key responsibilities 重要职责
Categories in headlines the key responsibilities that demonstrate the variety of roles that the organization expects the position to fulfill. List the main responsibilities in the job (3-6 headlines)

Ø Quality management system-GSP related.
Ø RDC received products confirmation
Ø Distributors management
Product Handling Related
Main job tasks 主要工作任务
For each headline indicated above the job tasks should be described in more detail.
Quality management system-GSP related
Ø GSP related QMS maintenance, e.g. CR, SOP and training.
Ø Improve and simplify GSP process.
Ø GSP L1 distributors QMS assessment.
Ø Prepare and attend GSP inspection internal/compliance check.
Ø Review and approve validation related documents.
Ø GMP products master data approval
Ø GSP user access approval in Novoaccess and offline
Ø RDC and Carriers master data check and approval
Ø GSP IT system development
Ø Other tasks assigned by line manager
RDC received products confirmation
Ø Review and confirm receiving documents from RDC.
Ø Temperature records evaluation.
Ø Handling product damage etc.
Ø Handling vendor’s deviation related to products confirmation.
Ø RDC training
Ø RDC license approval
Distributors management
Ø Distributors qualification assessment, e.g., license update or distributor addition.
Ø Distributors authorization review and approval.
Ø Distributor license archiving
Ø License data maintenance in SAP system.
Ø Yearly review of distributor’s Annual Report and quality management system information.
Ø Collection of distributor authorization material and review
Ø Search and collect distributor’s information on internet, analyze the impact of information on NN product, reputation, and take necessary actions.
Product handling related
Ø Nonconforming products destruction approval
Ø Return goods evaluation and approve
Ø Temperature excursion & other product quality issues handling.
Ø Product traceability, ESC
Ø Product status control
Ø Product master data approve
Education 教育背景
Required education and/or specific certification/course

· Bachelor degree in pharmaceutical or related area
· Good English communication skills in both written and spoken

Experience 经验
Year of related working experience required in the job

· At least 1 year working experience in quality in multinational companies of pharmaceutical field
· Broad knowledge is needed (familiar with basic processes in related department
· Be familiar with regulation relevant requirements (recall, AE…)

Personal skills 技能
List specific personal skills desired in the job to accomplish objectives and create value

· Good communication, cooperation and networking skills with internal & external stakeholders (most of the work need communication internally & externally)
· Strong analytical skills
· Honest and genuine and keen to influence/ persuade others about the point of view
· Be of strong sense of responsibility, patient and initiative
· Innovation
· Mature, independent, and team spirit