Job Description

For our client, one of the world’s most exciting healthcare company with global footprint in working on breakthrough solutions, we are looking for a prospective candidate:

Quality Assurance Country Lead

This position has primary responsibility to ensure that the Company Quality Management System is in compliance with the cGMP and cGDP. Provide QA support on Data Integrity and Systems Validation. He/she also ensures that the GCP, GLCP and GVP are properly embedded in the overall QMS.

  • Development, deployment and maintenance of the quality systems such as, but not limited to, documentation management, change management, CAPAs management,
  • Act as a Responsible for the legal requirements of products distribution,
  • Handling of Product Quality Complaints and Medical Device reports,
  • Main Quality contact for collecting and processing Change Controls and CAPAs with Third Parties
  • Manage the vendors' quality management system, including external audit program and maintenance of list of approved vendors
  • Collect Key Quality/Compliance Indicators for periodic review of local Quality management system
  • Manage internal audits (self-inspections) program by planning, executing, reporting and monitoring upon close-out
  • System administrator for eQMS
  • Monitor Quality Systems for trends and notify management of events requiring and immediate action.

Who you are:

  • University degree in pharmacy, Engineering, Natural Science or equivalent degree,
  • Local Pharmaceutical & Medical devices regulations knowledge.
  • Good Knowledge of GMP; GDP; ISO,
  • Strong understanding and interpretation of different regulations and best quality practices with regards to quality systems management,
  •  Project management and change management expertise with capability to identify and manage resource requirements,
  • Excellent communication skills with ability to communicate effectively both orally and in writing to both internal and external audience, 
  • Excellent communication, motivational and interpersonal skills with a teamwork mindset,
  • Advanced level of written and spoken English language,
  • Very good knowledge of MS Office.

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