Global Quality Auditor

Hiring By - Biostaffic

 BioPharma

Spain

Job Highlights

Not Disclosed

Posted 4 months ago
Job details

Global Quality Auditor

Reports to: Global Head of Quality


The company:

The organisation, a global pharmaceutical company headquartered in Spain, operates worldwide in scientific research, manufacturing, and marketing of pharmaceutical products for human health. It comprises three divisions: Industrial, Branded, and Biotech, with 6000+ professionals in 40+ countries, 15+ facilities, 10+ R&D centers, and 10 commercial offices. They serve 1,150 customers in 96 countries, focusing on innovation, sustainability, and affordable access to quality medicines.


Role Overview:

The Global Quality Auditor reports to the Global Quality Audit Regional Team Leader. Their main responsibility is to conduct GxP Quality audits on a global scale.


Responsibilities:

  • Supporting the development of a global risk-based audit strategy.
  • Planning, conducting, and documenting GMP audits worldwide in line with quality procedures and regulations.
  • Handling complex audits, including sterile API, aseptic DP, and combination products, by assessing risks effectively.
  • Providing technical guidance, mentoring, and training on audit activities.
  • Offering regulatory advice for remediation and filing recommendations.
  • Preparing audit reports, ensuring timely communication with audit sites.
  • Escalating critical findings and supporting follow-up actions.
  • Reviewing responses to audit findings and ensuring compliance with procedures.
  • Acting as a GMP compliance consultant for various projects.
  • Monitoring qualification activities and staying updated on regulations.
  • Identifying best practices and contributing to auditor development.
  • Reporting relevant metrics as requested.


Qualifications:

  • Advanced degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
  • Excellent English communication skills, and Spanish proficiency is a plus.
  • Minimum of 4 years' experience in GMP-regulated organizations.
  • Strong understanding of EU and FDA regulations for pharmaceutical R&D, manufacturing, and distribution.
  • Willingness to travel to upwards of 60%
  • Objectivity and consistency in audits, effective communication skills, personal integrity.


Email applicants please forward to; jake.tookey@discoverinternational.com. With a copy of your CV and your availability for an initial screening call.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Spain

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 15, 2024
Company Overview
Discover International
Discover International

Current Openings: 0

Discover International - Visionary Life Science Talent Solutions Our expert teams find exceptional people faster Our innovative Talent and Consulting solutions mean we deliver faster at every stage and every challenge of the hiring process; our product offering brings together an extensive global and local network, specialist skills, strategic guidance, and dedicated experts working together as a team. We nurture long-term partnerships with our candidates, our clients and our stakeholders, who continually recommend us to their colleagues and peers. When our contacts move to a new company, they consistently approach us to support them in finding talent in their new organisation. This organic client acquisition is testament to all that we stand for at Discover, and we are proud that more than 90% of our clients are repeat customers. We help game-changing organizations grow, making a meaningful difference at every stage of the Life Science process, through finding brilliant people faster in: Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Regulatory Affairs, CMC, Quality & Compliance, Medical Writing & Communications, HEOR, Market Access, Commercial, Pharmacovigilance & Drug Safety, Technical Operations, Manufacturing, Preclinical.
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