Head Of Quality Assurance

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
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.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Barrington James
Barrington James

Current Openings: 0

The global Life Sciences industry is dominant in today’s world. Drug development processes are progressing faster than ever before. The need for vaccines, treatments and medical devices continues to grow at an exponential rate to ensure treatment for disease reaches those it needs to. That means for Barrington James, we grow at the same speed. With 14 global offices specialising in niche areas of the Life Science industry, we are ready to support our growing group of clients in sourcing the most, senior, specialist and rare candidates to join them. Having grown in both size and reputation since 2002, we have an unprecedented and ever-growing network of specialist candidates and engaged clients, we are ever present and highly recognisable at global industry related conferences and we work hard to foster personal relationships that go beyond a professional transaction. We offer a wide range of services, and have the resources to create bespoke recruitment solutions, giving our clients an effective and efficient recruitment experience. Our Consultants are skilled at developing deep networks within specific, niche sectors of the Life Science industry, thus making them experts in their field. They are all highly trained, highly motivated and connected to the key information networks necessary for fast accurate recruitment. ‘We Invest In Our People’ through training and development, through meritocratic progression, and through unrivalled commission structures, shareholder and bonus schemes.
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