Head of Quality Management - Science & Research jobs in Malta - September 2019

Head of Quality Management

Pharma
Posted date 19/08/2019 |
Closing date 30/09/2019
Full Time Management

In this new role as a Head of QM, you will be reporting directly to the Head of Operations. Your main responsibilities will include:

  • Ensuring that each batch has been produced, tested/checked, released or reject, and imported (as applicable) in accordance with the respective current international legislation, the marketing authorisation and National Legislation
  • Permanently and continuously be at the disposal of the holder of the Manufacturing License to carry out their responsibilities
  • Reviewing and approve the manufacturing and QC documentation in order to carry out the release/rejection of finished product according to EU GMP
  • Providing managerial support for staff and decision making on day-to-day issues
  • Ensuring that staff is being adequately trained and well informed in relation to their role, duties and responsibilities
  • Setting up operational/strategic plans and coordination of department activities
  • Approving and control GMP documentation including SOPs, Batch Records, Master Batch Records, specifications, CAPA reports, Audit records.
  • Approving suppliers of critical services
  • Reviewing and approving validation protocols and reports ensuring the conformity with company’s Validation Master Plan, Quality System, GMP’s, Quality Risk Management and regulatory requirements
  • Developing and implementing internal and external audit plans

Education & Experience 

  • A Degree in Pharmacy or Chemistry & Biology
  • Minimum of 5 years experience in a QA/GMP Environment 
  • Experience working in an FDA Regulatory Environment and holding a QP status
  • Eligible to act as a Qualified Person for the finished product

Skills

  • Excellent proven management skills within a Quality Management position
  • Fluency in English is a must. Fluency in Maltese will be preferred
  • Excellent organizational and leadership skills
  • Conscientious and responsible
  • A keen eye for detail and a results-driven approach

Kindly submit your application directly to us using the 'Apply Now' button.

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