PharmEng Technology

Quality Assurance Associate (Pharmacist)

Posted: 1 hours ago

Job Description

MissionTo 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 ResponsibilitiesQuality System ManagementAssist 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 & ComplianceSupport GxP audits, inspections, and regulatory authority engagements.Participate in internal audits and inspections.Manage deviations, CAPAs, and change controls.Training & Quality OversightCoordinate and deliver GxP-related training.Monitor quality KPIs and perform annual quality reviews.Ensure quality oversight of subcontractors, including qualification and audits.Product Quality & DistributionHandle 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 FunctionsCollaborate 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 & SkillsRegistered Pharmacist with Singapore Pharmacy Board preferredNon-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.

Job Application Tips

  • Tailor your resume to highlight relevant experience for this position
  • Write a compelling cover letter that addresses the specific requirements
  • Research the company culture and values before applying
  • Prepare examples of your work that demonstrate your skills
  • Follow up on your application after a reasonable time period