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Quality Specialist Complaints - Remote

Roles & Responsibilities

  • Bachelor's degree in Pharmacy, Life Sciences, or related field
  • Proven experience in Quality Assurance/Quality Control and familiarity with QMS
  • Knowledge of regulatory requirements and experience coordinating regulatory inspections
  • Strong communication and cross-functional collaboration skills, and ability to work remotely

Requirements:

  • Developing and ensuring compliance with quality plans and programs
  • Coordinating regulatory inspections under the manufacturing and wholesale distribution licenses
  • Implementing regulatory compliance in cooperation with the Regulatory Affairs Manager
  • Recording and initial assessment of reported cases of drug risks or suspected cases where pharmaceutical-technical defects are involved

Job description

· Developing and ensuring compliance with quality plans and programs

· Coordinating regulatory inspections under the manufacturing and wholesale distribution licenses

· Implementing regulatory compliance in cooperation with the Regulatory Affairs Manager

· Monitoring of Group quality standards and their implementation in the local QMS

· Recording and initial assessment of reported cases of drug risks or suspected cases where pharmaceutical-technical defects are involved

· Collaboration and point of contact for Customer Service/KAMs/Medical Information and other departments regarding complaints.

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