Our Client an American MNC Company in Pharmaceutical Industries inviting suitably qualified applicants for the position of :

Responsibilities:

• Carry out management of Supplier Quality in Asia including qualification of new suppliers, routine audits, product inspections, ongoing surveillance and review of performance to ensure company requirements are consistently met.
• Ensure that products produced under agreements meet all quality and regulatory requirements.
• Review and approve contract sterilization of products which includes:
• Supervision of dose mapping, dose audits, product release (radiation)
• Cycle qualification, ER sterilization
• Laboratory Activity – Chemical CFU, routine screening of raw materials
• Maintain documented Quality system in accordance with ISO 13485 and United States FDA Quality System Regulations.
• Ensure supplier takes appropriate corrective actions to address customer complaints and provide response to customers.
• Ensure all labeling meets regulatory requirements.
• Liaise with other businesses in the US and Europe to identify quality requirements.
• Work with product development teams to identify new product requirements.
• Act as Management Representative for setting up and maintain quality system

Requirements:

• Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma or Professional Degree in Chemistry, Engineering or related Science disciplines or equivalent.
• At least 8 year(s) of working experience in Quality for Medical Device or Pharmaceutical Manufacturing is required for this position.
• Working experience with China vendors/suppliers.
• Supply Chain Management experience in compliance and contractual environment.
• Knowledge of SIO 13485 and US FDA Quality System Regulations.
• Familiar with Supplier Quality Management systems.
• Possess good communication skills both in English and Mandarin.
• Able to travel extensively in Asia.
• Applicants must be willing to work in Central.
• Preferably Managers specializing in Quality Control/Assurance or equivalent.
• Full-Time positions available.
  
  
  
• Interested candidate/s please send detailed resume via email to prisasia@globalprosearch.com.sg or call 6220 6586 Priscilla