QA Manager

Serbia · Full-time

About The Position

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.

Medison is rapidly growing in the international markets backed by 25 years of established operations in Israel, global infrastructure and partnership network. Medison is headquartered in Israel, with its international markets HQ in Switzerland and commercial hubs across the Baltics, Central and Eastern Europe, the Balkans, Greece as well as Canada.

Responsibilities

  • Participate in designing, implementing, maintaining, and improving quality systems. Ensure the QMS is compliant to regulatory requirements
  • This role will not only cover Greece but can be extended to other territories
  • Independently initiate and approve SOP updates and creation of new SOPs. Additionally, oversee review of SOPs and associated documentation to ensure review requirements are met
  • Provide hands on quality expertise to colleagues and partners to support their quality and business needs
  • Participate in vendor management program, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s Quality Management Systems
  • Work with QA Director to ensure Medison is compliant with latest regulatory and pharma trends related to GMP and GDP
  • Ensure/participate in self-inspections of Medison 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 highlight continuous improvements as appropriate
  • Ensure change control requests, deviations, complaints and CAPA’s are reviewed using risk-based principals to comply with applicable requirements
  • Participate in regulatory inspections as required
  • Participate in vendor management and oversight including vendor audits, and evaluation of their QMS, resources, premises, and equipment
  • Participate in recall and mock recall operations
  • Carry out any other duties that maybe reasonably required and assigned to you by your manager


Requirements

  • Bachelor’s degree in science or equivalent
  • At least 5 years’ experience in an active QA role
  • Excellent written and verbal communication skills
  • Fluent English is essential
  • Attention to detail
  • Quality function representative on various projects
  • Root cause analysis and investigation skills
  • Technical report writing
  • Strong knowledge in regulatory, cGDP and cGMP requirements
  • Proven track record in auditing and quality systems
  • Experience in regulatory inspections is desirable
  • Strength in critical thinking, problem solving, and decision making
  • Collaborative nature, self-directed and independent
  • Very strong organizational abilities
  • Excellent interpersonal skills and ability to successfully maintain professional and trusting relationships
  • Works effectively in highly dynamic and changing environments, displays agility
  • Willing to travel locally and internationally as needed