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Open nowPosted 21 days ago

Clinical Quality Executive

MyCareersFuture94,028 open roles

Pay
SGD 4,000 – SGD 6,000 a month
Where
West, Singapore
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Your applicationOpen nowClinical Quality ExecutiveMyCareersFuture · West, Singapore

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The clock on this job

Early applications get read.

7.8% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 1.6%1 day
  2. 3.4%3 days
  3. 7.8%7 days
  4. 14.3%14 days
  5. 33.7%30 days
This job: posted 21 days ago

The posting

Job Description:

  • Ensure clinical trial processes and procedures are conducted in accordance with GCP, relevant regulations, guidelines, protocol, and quality management system
  • Conduct quality risk assessment and ensure appropriate mitigation of risks
  • Manage document control of quality management system
  • Review and update SOPs and associated documents
  • Prepare and conduct internal process audits, study specific audits, site audits, vendor audits and relevant audit reports
  • Perform Incident/CAPA lifecycle management including root cause analysis, impact analysis and provide suitable recommendations for improvements
  • Perform computerized system validation where required
  • Assist in the conduct of quality management review meetings
  • Keep up to date with regulatory guidelines and legislations and utilize relevant documents to interpret for guidance
  • Conduct vendor qualification
  • Review of relevant clinical trial documents
  • Management of QMS-related and study-specific training
  • Other duties as assigned by line manager/HOD

Requirements/Skills:

  • Bachelor’s degree or equivalent in basic sciences
  • Experience in pharmaceutical industry with knowledge of EU, US and other relevant international regulatory standards and GxP guidelines for the conduct of clinical trials
  • Experience in clinical/regulatory auditing desirable
  • Effective oral and written communication skill
  • Strong analytical and problem-solving skill
  • Good computer skills, inclined to adapt to technology efficiently
  • Results-oriented, multi-tasking, quick learner
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