Pharmaceutical Quality Professional

7 days ago

Singapore beBeeQuality Full time $100,000 - $120,000
Job Overview:

The Commercial Quality Manager will be responsible for ensuring the quality of pharmaceutical products in various countries. This includes overseeing regulatory compliance, managing local suppliers, and implementing a quality management system.

Key Responsibilities:
  • Ensure quality oversight and regulatory compliance of products marketed in the country.
  • Manage local 3rd party suppliers/manufacturers/distributors.
  • Roll out a quality management system.
  • Attend quarterly quality councils.
  • Provide monthly quality metrics.
Market Release:
  • Ensure market release from approved suppliers based on batch release documentation and transport conditions documentation.
  • Ensure distribution traceability of finished products and returns of products commercialized in the country.
Distribution:
  • Ensure GDP compliance of distribution centers.
Complaints and Recalls:
  • Register quality complaints and liaise with manufacturing sites to trigger investigations and corrective actions.
  • Liaise with pharmacovigilance department in case of recall.
Change Control, Deviations, and CAPAs:
  • Administer, maintain, and develop systems for change control, deviation, and CAPA handling.
Distributors, Suppliers/Manufacturers, and 3rd Party Service Providers:
  • Maintain, monitor, and approve a list of approved 3rd parties.
Archiving:
  • Ensure relevant quality-related documentation is archived as required.
Critical Quality Incidents:
  • Report critical quality incidents to management.
Qualifications & Experience:
  • Bachelor's degree in Pharmaceutical Sciences, Business, Healthcare, or equivalent combination of education and experience.
  • Minimum 2-4 years' experience as a Quality Manager/QP in a pharmaceutical company or importer/distributor.
  • Demonstrated knowledge of PIC/S GMP and GDP and government regulations for the country.
  • In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance.

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