Real Staffing

QA QMS

Location: Nazareth, Flanders, Belgium
Salary: Up to £4500 per annum + -
Job Type: Permanent
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  • Act according to the Quality Assurance (QA) vision, strategy and standards for the group.
  • Support the maintenance of the Quality Management System as SME (including assessment and implementation of new regulations eg MDR)
  • Ensure ongoing awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD etc)
  • Identify gaps and areas for improvement in QA processes and lead remedial actions and initiatives.
  • Maintain databases and documents according to good documentation practices and record retention procedure.
  • Active support in the implementation, maintenance of Quality Systems, including electronical systems (including Trackwise, LMS),
  • Support validation activities of electronic systems
  • Provide QA training regarding QA systems and processes and procedures and evaluate training effectiveness.
  • Support in the design and implementation of key performance indicators to verify efficiency and effectiveness of processes and procedures to agreed standards.
  • Identify individual serious complaints that may result in market action or similar and to ensure adverse event complaints are identified and handed to safety group for evaluation and regulatory reporting.
  • Ensure effective investigation (including non-conformity handling) of complaints and other deviations, including root cause analysis and defining CAPAs for short term and long term improvements.
  • Active participation in the Monthly Complaint Review Meeting
  • Evaluate and follow-up Change Controls together with the Regulatory Affairs team and other departments as required.
  • Prepare Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
  • Support / Perform internal QA audits.
  • Ensure ongoing inspection readiness in your area of responsibilities.

  • Master's degree in pharmaceutical sciences, engineering, biochemistry, chemistry … or equivalent through experience.
  • At least 5 years relevant experience in QA in the pharmaceutical (or associated) industry.
  • Knowledge of the relevant European regulations for pharmaceutical products (GMP, GDP), Medical Devices (MDR, MDD, ISO13485, ISO14971), Food, Food Supplements (HACCP, ISO 22000) Cosmetics (ISO 22716) is desired
  • Self-starter, capable of working autonomously in an international environment.
  • Clear communicator, practical and solution orientated.
  • Enthusiastic work attitude
  • Strong project management skills & team worker in a multicultural environment.
  • Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills.
  • Not afraid to travel occasionally
  • You can speak and write fluently in English. Other languages are an asset.

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