Manager External audits, Asia

Manager External audits, Asia

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Job details


Wuxi
2019-01-07 12:44
27848
Quality/Safety
Pharmaceuticals

Job description


Our client is a global pharmaceutical company with clinical nutrition and generic drugs. They are currently looking for a Manager External Audits, Asia.

TARGET OF THE POSITION

  • Auditing of external suppliers in Region Asia
  • Quality Assurance Support of Sourcing Managers in Region Asia

POSITION IN THE COMPANY

  • BU API
  • Manager External Audits Asia
  • QA Global API Sourcing

MAIN TASKS

  • Performance of external supplier audits (Active Pharmaceutical Ingredients, excipients, Starting materials) in region Asia (mainly China, East Asia)
  • Follow up of Corrective & Preventive actions
  • Handling of Quality issues of API suppliers in region Asia

SECONDARY TASKS

  • Coordination of cost efficient and timely qualifications for new suppliers or materials in Region Asia (especially China and east Asia)
  • Quality assurance support for Global API& RM Sourcing Managers Asia
  • Co-ordination of quality related projects with API suppliers

SPECIAL TASKS / ADDITIONAL TASKS

  • Identify regulatory trends for APIs in region Asia
  • Establish network of Auditors in co-operation with manufacturing units

REQUIRED BUSINESS CONTACTS

Internal

  • Divisional QM, Global Sourcing, Business Units, Global Operations and Manufacturing Units (purchasing/ quality assurance/ Quality control), Regional Regulatory Affairs

External

  • Suppliers

REPRESENTATION

  • The job holder represents: Senior Manager External Audits Asia
  • The Job holder is represented by: Senior Manager External Audits Asia

QUALIFICATION AND EXPERIENCE

  • Scientific background (university degree) preferably Pharmacy or chemistry
  • 2-4 years of experience in the pharmaceutical industry (Quality Assurance or Quality control)
  • Experience in GMP audits specifically for APIs (following ICH Q7)

REQUIRMENTS/KNOWLEDGE TO FULFIL POSITION

  • Profund knowledge in GxP regulation (China, US, PIC/s, EU)
  • Basic knowledge in Registration procedures in Asia (especially China), US and Europe
  • Experience in auditing
  • good computer skills (MS Office, SharePoint)
  • fluent in English and mandarin
Qualified and interested Parties please apply with your CV and latest salary in Word format to kate.li@morganphilipscn.com
THE DIGITAL HEADHUNTING COMPANY
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