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QA Compliance Specialist

Job description

POSITION RESPONSIBILITIES

  • Lead the preparation activities for the submission of the site Manufacturer’s Importation Authorisation (MIA)/Commercial GMP license application
  • Lead the preparation of the Site Master File and associated site documentation required as part of MIA submission
  • Support for related Compliance deliverables in support of audits and inspection readiness
  • Provide Quality and cGMP input and support for audit and inspection readiness activities
  • Support the site Document / SOP management systems
  • Support for various GMP and Quality Training programs & Knowledge Management activities
  • Other general specified tasks e.g. global quality metrics, internal audit metrics

 

QUALIFICATIONS AND EXPERIENCE

  • Degree in natural or applied sciences (Biotechnology, Pharmacy, Biology, Engineering)
  • Minimum 5 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role
  • Experience of MIA submissions, Site Master File compilation and electronic quality management system tools is required

 

  

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