Quality Assurance Associate

20 hours ago

Singapore PharmEng Technology Full time $60,000 - $90,000 per year

Mission

To support the implementation and maintenance of the Quality System to ensure compliance with global standards and local GxP regulations, ensuring patient safety and business support.

Key Responsibilities

Quality System Management

  • Assist in implementing and maintaining the system.
  • Manage quality documents and ensure alignment with global and local requirements.
  • Provide guidance on local quality document development and training.

Audit, Inspection & Compliance

  • Support GxP audits, inspections, and regulatory authority engagements.
  • Participate in internal audits and inspections.
  • Manage deviations, CAPAs, and change controls.

Training & Quality Oversight

  • Coordinate and deliver GxP-related training.
  • Monitor quality KPIs and perform annual quality reviews.
  • Ensure quality oversight of subcontractors, including qualification and audits.

Product Quality & Distribution

  • Handle product quality complaints and recall processes.
  • Monitor temperature excursions and distribution-related issues.
  • Ensure GDP compliance in distribution and logistics.

License Holder Duties (Wholesale/Import)

  • Maintain GDP/WDL licenses and related documentation.
  • Ensure quality system implementation for import and wholesale activities.
  • Oversee product returns, recalls, supplier/customer validation, and self-inspections.

Support Functions

  • Collaborate with Regulatory Affairs, Medical, Pharmacovigilance, and Supply Chain.
  • Ensure accurate records of training, roles, and systems used in GxP functions.
  • Provide backup support in absence and contribute to quality budgeting.

Qualifications & Skills

  • Registered Pharmacist with Singapore Pharmacy Board preferred
  • Non-pharmacists with relevant experience in quality assurance, compliance, or pharmaceutical distribution are also welcome to apply.
  • 1–2 years of experience in health-regulated industries; fresh graduates with pharmacist license keen for a career in the pharmaceutical industry are welcome to apply.
  • Knowledge in GDP, GMP, QMS, risk management, and pharmacovigilance.
  • Strong communication, problem-solving, and project management skills.
  • Demonstrated teamwork and growth mindset.

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