Process Deviations Investigation Senior Specialist (f/m/d)

Role Overview

We are seeking an experienced professional to lead process deviation investigations within Manufacturing. In this role, you will coordinate cross‑functional collaboration, identify root causes, assess risk, and define effective CAPA focusing particularly on major and critical deviations.

Key Responsibilities

• Lead and document investigations including root cause analysis, impact assessment, risk evaluation, corrective actions, and CAPA.
• Act as the owner of process deviations and ensure timely closure in alignment with QA Operations.
• Ensure documentation meets procedural, regulatory, and quality standards.
• Collaborate with SMEs and cross‑functional teams to gather and validate information.
• Prepare reports from Quality Systems and analyze KPI‑related data.
• Participate in Deviation and CAPA review boards when required.
• Identify opportunities to improve processes, documentation, and investigation effectiveness.
• Represent the team in cross‑functional and external meetings (e.g., with auditors, consultants).
• Share knowledge within the team and broader organization.

Qualifications

• Higher education in chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine, or related field.
• 6+ years of experience in the pharmaceutical or biotechnology industry.
• 6+ years of direct QMS experience (deviations, CAPA, OOS, etc.).
• Advanced English proficiency (spoken and written).
• Strong understanding of biotechnology manufacturing processes.
• Experience with regulatory inspections (GIF, FDA, EMEA).
• Excellent organizational and time‑management skills; ability to manage multiple tasks.
• Strong analytical and conceptual thinking skills.
• Ability to translate technical language into clear, reader‑friendly content.
• Proficiency in Microsoft Office.
• Effective communication and teamwork skills; ability to work independently.
  
  

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.

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!