Production Compliance Senior Specialist

Rezonbio

Duchnice, PL
Base: competitive salary; bonus/equity: annual + s...
On-site
Gmp process documentation management
Fda compliance knowledge
Batch record review and analysis
The role ensures product quality compliance with specifications, supporting product registration, preclinical studies, technical-scale implementation, and commercial production

Job Summary

  • The role ensures product quality compliance with specifications, supporting product registration, preclinical studies, technical-scale implementation, and commercial production.
  • Employees receive a competitive salary with annual and special occasion bonuses, a comprehensive benefits package including private medical care, life insurance, and financial support for skill development.
  • Rezon Bio promotes diversity and equality with a transparent recruitment process respecting non-discrimination principles regardless of gender, age, orientation, or identity.

Matching Summary

The role ensures product quality compliance with specifications, supporting product registration, preclinical studies, technical-scale implementation, and commercial production.

Salary

Base: Competitive salary; Bonus/Equity: Annual and special occasion bonuses; Benefits: Private medical care, life insurance, pension programs, paid day off, Flex Benefits budget, free transportation, cafeteria, psychological support

Skills & Requirements

Must-have

  • GMP process documentation management
  • FDA compliance knowledge
  • Batch record review and analysis
  • Process evaluation reporting
  • Cross-department collaboration
  • CAPA implementation
  • MS Office proficiency

Nice-to-have

  • Strong communication skills
  • Flexibility and teamwork
  • High accuracy and attention to detail
  • Problem solving and time management

Key Requirements

  • Master’s degree in biotechnology or related field
  • Minimum 3 years professional experience
  • Up to 1 year in biotechnological or pharmaceutical production
  • Strong knowledge of cGMP and FDA requirements
  • Very good English proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter