Head of Quality Assurance

Frankfurt
18-01-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Quality Assurance- GMP
Salary Type
Annual

Job Description

Head of Quality Assurance and Compliance 

  • Design and execute a comprehensive Quality Assurance system compliant with CGMP (ICH Q7) for all activities conducted at the production and analytics site.
  • Hold responsibility for overseeing Quality Assurance in the realm of chemical-synthetic production of peptide active ingredients for Clinical Phase I and Phase II A at the Frankfurt site.
  • Collaborate with the global unit (Corporate Compliance) to implement cross-site requirements, engaging in proactive dialogue with regulatory authorities and seamlessly incorporating their requirements into the expansion project.
  • Serve as the coordinator for SHE matters within the line function, holding legal responsibility for occupational health and safety vested in the management and executives.
  • Prepare, support and ensure the follow-up of inspections by regulatory authorities and customer audits.
  • Conducted training courses for employees focusing on GMP and Q-system adherence.

 

YOUR PROFILE

  • Possess a background in completed scientific or technical studies.
  • Qualification as a Qualified Person according to § 14 AMG is an added advantage.
  • Accumulated over eight years of experience in quality management/quality assurance within the pharmaceutical industry (GMP).
  • Known for a structured and conscientious approach, organizational talent, independence, and the ability to thrive under pressure.
  • Demonstrated expertise in conceptualizing and developing quality systems.
  • Stay updated on current data integrity requirements.
  • Exhibit customer-oriented thinking, teamwork proficiency, and quick comprehension skills.
  • Dependable, precise, and punctual work ethic with a strong commitment to quality and hygiene.
  • Desirable knowledge of environmental, health, and safety at work.
  • Show motivation to familiarize yourself with new topics and flexibility in handling diverse responsibilities.

 

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