QA Systems Specialist (female/male) (maternity cover)

The role is responsible for the implementation, monitoring, and maintenance of the Quality Management System (QMS). This includes ensuring that all activities within the scope of responsibilities are executed in compliance with applicable procedures, as well as coordinating with cross‑functional teams to ensure timely completion of QMS documentation.

Main responsibilities

• Perform all duties in compliance with current GMP, GDP, Data Integrity regulations and other applicable pharmaceutical requirements.
• Facilitate, oversee and actively participate in Deviation, CAPA/(s)CAPA processes, including effectiveness checks, extensions and escalations.
• Support implementation and upgrades of Quality Management System (QMS)–related applications.
• Prepare and review quality documentation in accordance with legal requirements, GMP standards and Quality/Technical Agreements (QAA).
• Participate in data collection and analysis for KPI calculations related to QMS elements and associated reports.
• Present QMS‑related data during internal review meetings.
• Prepare and revise SOPs and Work Instructions related to the Quality Management System, ensuring QA compliance.
• Develop quarterly and annual trend reports for QMS elements.
• Adhere to workplace safety and environmental protection principles.
• Perform additional duties as assigned by the supervisor.

Requirements

• Master’s degree in biology, chemistry, pharmacy, biotechnology or a related scientific field.
• Minimum 5 years of professional experience in the pharmaceutical industry.
• Strong knowledge of GMP requirements and pharmaceutical regulations, with particular focus on the ICH environment.
• Solid understanding of Quality Management Systems (QMS).
• Good command of English, both written and spoken.
• Proficiency in MS Office applications.
• Strong communication skills.
  
  

What we offer

• Employment at a leading company in Poland’s biotechnology sector.
• Engaging and meaningful professional challenges.
• Competitive salary with annual and special occasion bonuses.
• Attractive benefits package, including:
• Private medical care.
• Life insurance.
• Employee Pension Program (PPE) and Employee Retirement Support (PWE).
• One additional paid day off per year.
• Flex Benefits budget (choose from options like MultiSport or Pluxee lunch card).
• Financial support for skill development.
• Free transportation to the workplace (2 dedicated lines).
• On-site cafeteria serving fresh breakfasts and lunches, with live cooking once a week.
• Weekly fruit and vegetable days.
• Access to psychological support.

Important: Please ensure that your application is submitted in English. 

At Rezon Bio, we believe in diversity and equality. Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles – regardless of gender, age, orientation, gender identity, or other individual characteristics. We encourage all individuals who meet the requirements to apply, including women, men, and non-binary persons. What matters most to us is your experience, skills, and passion for achieving goals together!