Overview

Description

  • Support Senior QA Compliance Specialist/Compliance Supervisor and/or lead in change control management
  • Create or revise quality systems documents following applicable policies, process and procedures
  • Assist with internal/external audits scheduling, documentation preparation, execution of audits
  • Maintain and monitor Annual Product / Quality Review (APR and PQR) schedules until completion
  • Track compliance area metrics as required
  • Maintenance of master listings (e.g. Audit CAPA listing, Change Plans listing)
  • Track and drive the periodic review exercise of compliance activities/documents (e.g. Quality Agreements, Audits)
  • Maintain, organize, scan and retain documentation in the compliance area
  • Conduct GMP, Quality Systems Related Trainings

Qualifications

  • Degree in Sciences (e.g. Biology, Chemistry), Pharmacy, or Engineering Degree or equivalent
  • Knowledge of quality / compliance areas as well as regulations and standards affecting APIs and Biologics is desired
  • Minimum 3 years working of experience in (GxP) environment is required and in quality area is desired
  • A strong knowledge of regulatory requirements
  • Possesses a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times
  • Good problem solving skills and the able to adapt to new regulatory requirements
  • Total commitment to quality and maintain a high standard of work at all times with highest level of integrity and a strong work ethics

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