Senior Compliance Analyst
CooperVision
Costa Rica
hace 18 días

JOB SUMMARY

Directs and coordinates the Infrastructure Projects & Maintenance, and Safety / Environmental Department activities personally or through his / her subordinates

ESSENTIAL FUNCTIONS

  • Management Review
  • CAPA Board
  • Compliance Internal & Supplier Audits
  • Compliance External Audits (FDA - ISO - Japan (PAL)
  • Training on Quality System Regulations
  • Control Documentation
  • Purchase Controls
  • Identification and Traceability Regulatory Requirements
  • Establishing Non-Conformance Management Procedures
  • Monitoring Non-Conformance Procedures
  • Monitoring Quality Systems
  • Communication Feedback Issues
  • Quality Annual Reports
  • Regulatory Audits
  • Documentation of Regulatory Affairs
  • Training on Regulatory Affairs
  • POSITION QUALIFICATIONS

    KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of GMPs / QSR
  • Excellent oral and written communication skills in English and Spanish
  • Service oriented
  • WORK ENVIRONMENT

  • Occasional lifting
  • Prolonged sitting in front of a computer
  • Potential exposure to chemicals and hazardous energies
  • Potential exposure to high sound levels
  • EXPERIENCE

  • Two to three years of experience in a similar position in a medical devices / pharmaceutical industry
  • The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work.

    This is not an exhaustive list of all duties and responsibilities. CooperVision, Inc. reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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