• 516-522-2570

  • info@apteekpharma.com

  • 626 RexCorp Plaza Uniondale
    New York 11556

Clinical Quality Control


The position assists the clinical quality assurance team to develop clinical quality procedures and ensure quality oversight. This position is also responsible for ensuring clinical processes are conducted in accordance with GCP, GLP and PV guidelines.

Responsibilities:

  • Ensure that all processes contributing to the performance of a clinical trial are conducted properly
  • Troubleshoot clinical trials and activities
  • Manage and maintain databases for the quality system
  • Assist in strategic CQA planning and risk assessment
  • Report the status of the quality levels of staff, systems and production activities
  • Preside over improvement programs
  • Follow-up on audits and ensure corrective actions are completed and implemented
  • Evaluate quality events, incidents, queries, and complaints
  • Investigate GCP related issues and ensure development of corrective action plans
  • Keep up to date with all related quality legislation and compliance issues
  • Compile and review documents for regulatory submission
  • Document internal regulatory processes
  • Develop metric reports for CQA management and ensure regulatory rules are communicated through corporate policies and procedures
  • Assume a lead role for the preparation, conduct, and responses to regulatory agency
  • Provide leadership and strategy in line with global strategic objectives

Eligibility: Minimum Bachelor’s degree in biological sciences, pharmacy or related field and relevant experience.
Current Openings

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