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Quality Assurance Manager, Poland (Contractor)

Hungary · Contractor

About The Position

Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.

Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in international markets.

The Quality Assurance Manager is an experienced professional and a member of the EPM QA team, supports several territories and reports directly to the Quality Assurance Associate Director, EPM. The QA Manager plays a vital role in maintaining the quality system across the countries within scope and actively contributes to EPM Quality Team initiatives and activities.

Responsibilities

  • Participate in designing, implementing, maintaining, and improving the quality system.
  • Independently initiate and review SOP updates and create new SOPs.
  • Oversee review of SOPs and associated documentation to ensure periodic review requirements are met
  • Provide hands-on quality expertise to colleagues and partners to support their quality and business needs
  • Participate in GxP vendor management program, vendor oversight, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s Quality Management Systems, resources, premises, and equipment
  • Work with QA Associate Director to ensure Medison is compliant with the latest regulatory and pharmaceutical regulations and trends related to GMP and GDP
  • Ensure/participate in self-inspections of GMP/GDP operations are performed to schedule and identified CAPA’s are closed to plan
  • Participate in Medison Management Review to assess the effectiveness of the QMS and to implement continuous improvements as appropriate
  • Ensure change control requests, deviations, complaints and CAPA’s are recorded, reviewed and competed using risk-based principles to comply with applicable requirements
  • Participate in regulatory inspections and supplier audits as required
  • Participate in recall and mock recall operations
  • Carry out any other duties that may be reasonably required and assigned to you by your manager
  • This role covers the South Cluster (among others: Serbia, Croatia, Slovenia, Bosnia, Montenegro) and Hungary but can be extended to other territories

Requirements

  • Degree in science or equivalent (pharmacist is the preferred option)
  • At least 3 years’ experience in an active QA role in health care sector
  • Strong knowledge of regulatory, GDP and GMP requirements
  • Excellent written and verbal communication skills
  • Experience as quality auditor
  • Experience in regulatory inspections is desirable
  • Quality function representative on various projects
  • Root cause analysis and investigation skills
  • SOPs and other quality documents creation
  • Strength in critical thinking, problem solving, and decision making
  • Collaborative nature, self-directed and independent
  • Very strong organizational abilities
  • Fluent English