Quality Assurance Specialist

About The Position

Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.

As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.

Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.

We are a dynamic, fast-paced company, operating in over 25 countries on 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!

The position includes all aspects of quality assurance for all companies in the group. Job includes: Drafting new SOPs and updating existing SOPS and reports according to GMP and GDP regulations. Build and follow up work processes, set yearly training and conduct continuous training sessions for employees and suppliers. Document training. Conduct validation and monitor prevention and improvement activities (CAPA). Assist in preparing for inspections, executing internal auditing and partner audits as needed. Qualify suppliers, manage investigations and deviations. Risk management and support regulatory and operations divisions. Prepare specified yearly quality reports and be of assistance to manager in any way required.

Quality activities are not inspections, rather supervision. The purpose is to coordinate the company's management and regulatory efforts in a specific field.

Responsibilities

• Ensure that the quality assurance system is implemented in a way that the approved activities can be managed.
• Ensure precision and quality where listed and approve inspected documents.
• Supervising that employee training is implemented and maintained.
• Handle changes and deviations according to managers' requirements. Implement preventative and correction measures when necessary.
• Ensure implementation of periodic management survey.
• Ensure implementation of risk management.
• Ensure that suppliers and partners are approved and qualified.
• Approve every activity performed by sub-contractor that may indicate the quality of the
• products.
• Implement and ensure that internal inspections are carried out regularly and according to a set plan and ensure that corrective actions are set up after inspections.
• Keep account of all assignments carried out for person/company.
• File all relevant documentation.
• Carry out any task requested by superior.
• The role includes leading, coordinating and performing, validation and calibration activities in the warehouse areas and distribution-- vehicles. Occasionally, early work hours are require
  
  

• Scientific and or technical background of at least two years in the quality system of a manufacturer, importer, or pharmaceutical trading company. Academic degree.
• Familiarity with the Veeva eQMS system is an advantage
• Certification as an internal auditor is an advantage