Production Compliance Senior Specialist

The person in this position will be responsible for managing, controlling, and reviewing process documentation related to the manufacturing of biotechnological products in accordance with GMP principles and FDA requirements. The purpose of the role is to ensure product quality compliance with specifications, enabling product registration, preclinical studies, technical-scale implementation, and commercial production

Main responsibilities

• Timely review of batch records and minimizing comments following QOps team review.
• Analyzing process results for compliance with technological documentation and internal requirements.
• Providing supervisors and relevant teams with reports and documentation necessary for process evaluation.
• Informing the supervisor about any irregularities in the process, documentation, or task status.
• Monitoring, recording, and reviewing process documentation in accordance with GMP and the internal quality system.
• Preparing documentation in line with GMP principles and company requirements.
• Reporting work progress, task status, and preparing reports on completed activities.
• Collaborating with Technical Operations, Quality, R&D, and other departments across the organization.
• Developing procedures, work instructions, and equipment operating instructions.
• Supporting the Process Support Department in executing activities, including quality records.
• Participating in audits and inspections.
• Participating in or leading investigations related to quality deviations and implementing CAPA actions.

Requirements

• Master’s degree in biotechnology, pharmacy, or a related field.
• Minimum 3 years of professional experience, including up to 1 year in biotechnological, pharmaceutical, or related production.
• Strong knowledge of cGMP principles and FDA requirements.
• Experience in maintaining process documentation in accordance with GMP.
• Ability to solve problems independently and excellent time and work organization skills.
• Very good command of English, both spoken and written.
• Proficiency in MS Office.
• Strong communication skills, flexibility, and ability to work effectively in a team.
• High accuracy, attention to detail, and responsibility.

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!