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Senior Quality Assurance Executive, APAC | Pharma MNC

Job details

Location: Singapore
Job Type: Permanent
Discipline:
Reference: HCLS/EP/SQAE/2610C
Posted: 19 days ago
Consultant: Ewen Poh
Consultant Email: email Ewen
Consultant Phone: +65 6950 0365

Job description

Responsibilities

  • Providing support to the maintenance and improvement of Quality Management Systems of the company in compliance with Singapore’s Guidance of Importers and Wholesaler licences
  • QMS Management
    • Assume the Quality Management Representative (QMR) within the organization and main Quality Management system (QMS) contact person for external audits and regulatory inspections
    • Promotion of Quality Management Systems (QMS) awareness within the organization
    • Coordinate and participate in internal audits, external audits, management review to ensure that the requirements for compliance are met
    • Stay up to date and build expertise in product regulations and industry best practices (e.g. Good Distribution Practices (GDP) and Good Distribution Practices for Medical Devices (GDPMDS), ISO 13485, importer and wholesaler regulations)
    • Lead the post audit process to ensure correction action activities are supported by accountable staffs through effective implementation
    • Review and ensure closure of non-conformance (NC) and CAPA
  • Product Quality Complaints Management
    • Liaising with the local quality-responsible persons and the manufacturers on the product complaints
    • Assist in the investigation of the product complaints
    • Follow up and ensure that product complaints are closed
  • Product Recalls
    • Coordinates and manage product recall activities with relevant departments
  • Incoming Release
    • Perform incoming release checks (batch release) to ensure products are in compliance
  • Business Licenses
    • Acts as the company’s Responsible Person to liaise with Health Sciences Authorities on matters pertaining to the company’s import and wholesale licences
    • Acts as Form A License Holder
    • Maintenance of business licenses (import license, wholesale license etc) for both Medicinal Product and Medical Devices
  • Permit Applications
    • Apply for Import for re-export permits and miscellaneous permits from Health Sciences Authority, if required

Experience

  • Singapore Registered Pharmacist – Degree in Pharmacy
  • 3+ years of technical experience in pharmaceuticals / medical devices industry with oversight of QMS systems
  • Capable of handling regulatory and quality compliance programs independently
  • Up-to-date with industry-standard quality practices and international standards, e.g. GDP, GDPMDS, ISO 13485, etc.

Please contact Ewen Poh at +65 950 0365 or charterhousehealthcare@charterhouse.com.sg for a confidential discussion

EA License no: 16S8066 | Registration no: R1550486

Only successful candidates will be notified.