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Quality Assurance Investigations Coordinator At Viatris Egypt

Quality Assurance Investigations Coordinator At Viatris Egypt

 

Quality Assurance Investigations Coordinator At Viatris Egypt
Quality Assurance Investigations Coordinator At Viatris Egypt

 

 

 

Position summary:

  • Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory standards.
  • Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site.
  • Coordinating and Performing investigations together with responsible person.

Job Specific technical/Functional/Professional Competencies:

  • Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory standards.
  • Preparation of monthly quality metrics to follow-up the performance of deviations handling system.
  • Responsible for performing the “Deviations Handling system related to manufacturing, complaints, and laboratory”.
  • Responsible for approving and follow-up of the Corrective Actions/Preventive Actions generated from investigations, complaint, PMSI & others.
  • Share in the preparation of quality-related audits conducted by Corporate and regulatory agencies.
  • Share in the preparation of the issues that require Quality Council attention.
  • Member of the Internal Audit Team.
  • Accountable for QTS actions (CCR/Investigations/Interims, etc.).
  • Development of various risk assessments.
  • Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA and ALCOA+ principles all over operations.
  • Responsibility for compliance with Viatris Quality Standards.
  • Active implementation of Notification to Management procedures.
  • Responsibility for compliance with Viatris Quality Standards.
  • Accountable for authoring quality related documentation (SOPs, Controlled documents, Risk assessments, Standard testing procedures, …etc.).
  • Delegate for QA investigation Senior Associate in case of his absence.

Experience and Knowledge:

  • Bachelor’s degree in pharmaceutical sciences.
  • From 1-2 years of experience with a strong technical background in cGMP and Quality Operations in Pharmaceutical field.
  • Experience in manufacturing processes is a plus.
  • QRM Practitioner.
  • HP Practitioner.

Essential Personal Qualifications

  • Excellent in communication, teaching, and coaching skills.
  • Decision-making based on a risk science-based approach.
  • Good command of English both written and spoken.
  • Knowledgeable with interpersonal learning.
  • Logic way of thinking with high analytical skills.
  • Good planning and organization skills.
  • Strong interpersonal and influential skills.
  • Professional in reports and technical writing.

Preferred Qualifications:

  • Six Sigma (Yellow/Green belt).
  • Expert in all types of Events (Incidents/Investigations, LIRs, Complaints and EHS).
  • Experience with relevant TrackWise modules.
  • Experience in PQS/WHO requirements.
  • QRM practitioner.
  • Experience in QA/ QC/Compliance

Apply Here

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