Senior Lead Investigator

Polypeptide Group

Braine L'Alleud, Belgium
Competitive pyckage; bonus available; compyny car,...
On-site
Gmp environment experience
Deviation investigation management
Root cause analysis (rca)
Polypeptide Group is seeking a Senior Lead Investigator for its Braine L'Alleud site to manage and conduct thorough investigations related to deviations in a GMP manufacturing environment for pharmaceutical active ingredients. The role also involves ensuring compliance with regulatory standards and fostering a culture of continuous improvement

Job Summary

  • The role involves leading rigorous scientific investigations into deviations within a GMP pharmaceutical manufacturing environment to ensure regulatory compliance.
  • Candidates will be responsible for tracking quality KPIs, managing CAPA tasks, and ensuring timely closure of deviations and change controls.
  • The company offers a competitive compensation package including a company car, bonus, flexible work arrangements, and opportunities for professional growth.

Matching Summary

Match Score: 85

Polypeptide Group is seeking a Senior Lead Investigator for its Braine L'Alleud site to manage and conduct thorough investigations related to deviations in a GMP manufacturing environment for pharmaceutical active ingredients. The role also involves ensuring compliance with regulatory standards and fostering a culture of continuous improvement.

Salary

Competitive package; Bonus available; Company car, meal vouchers, group insurance included

Skills & Requirements

Must-have

  • GMP environment experience
  • Deviation investigation management
  • Root cause analysis (RCA)
  • CAPA planning and closure
  • Regulatory compliance (ICH Q7, 21 CFR)
  • Technical writing skills

Nice-to-have

  • Leadership and team development
  • Continuous improvement mindset
  • Client audit support experience
  • Strong analytical thinking
  • Cross-functional collaboration

Key Requirements

  • Master's degree or equivalent in Chemistry, Biotechnology, or Pharmacy
  • 5 to 8 years of experience in pharmaceutical industry
  • Experience with BPF/ICH Q7 and 21 CFR Part 210/211 regulations

Work Rights

Not specified

Tailored Resume

Cover Letter