长沙招聘

Required Education and Certificate (minimum requirements)
·Bachelor degree in pharmaceutical or related area
·Be familiar with specific knowledge (ISO)
·Good English communication skills in both written and spoken

Required Professional Experience (minimum requirements)
·At least 1 year working experience in quality in multinational companies of pharmaceutical field
·Broad knowledge is needed (familiar with basic processes in each department and NNHK & NNPTW)
·Be familiar with SFDA relevant requirements (recall, AE…)

Specific personal and job related demands
·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

Key areas of responsibilities and main job tasks
1)·Document control in Region China, including NNCP, NNHK, and NNPTW
·Document control
·Draft new/update SOPs
·SOP format check
·understanding complex compliance guideline/policies and developing comprehensive and practical local SOPs.

2)·Region China Quality management system maintenance:
·Follow up QBIQ weekly news
·Follow up of QBIQ SOP comments
·Maintain QBIQ profile as QBIQ administrator
·Ensure Non conformity and Change Request are identified, handled and documented
·Review temperature record
·Check NP4 promotion material
·Archiving of QA documents (using OmniRIM)
·Check labeling documentation
·ISOtrain system super user to ensure the distribution of all trainings
·OmniRIM system super user to ensure the compliance on archiving
·QAP placement, implementation and follow up;
·Responsible for packaging material (insert, label, carton) distribution in NNCP
·Respond to questionnaires and surveys requested by different HQ groups regarding process, procedure and education.

3)·Perform internal audits and inspections in Region China:
·Coordinate within the organization on HQ quality audit every year and make corrective actions for audit NCs and follow up
·Perform self-inspection and local internal audit to all affiliates (NNHK & NNPTW) in Region China and all departments in NNCP to ensure business practices and activities are in compliance with NN standards and local requirements.

4)·Perform quality training within Region China and quality team to improve quality mindset to all employees:
·QA introduction in orientation training
·Quality mindset training in sales training
·QA team training, include daily work and relevant topic training
·Organize QA team meetings
·QA training to each department to improve quality mindset

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