GMP Quality Auditor

Job Description:

In brief 💡

Position: GMP Quality Auditor

Location: Madrid, Spain

Experience: 10–12 years of experience in GMP-regulated environments

Want to know more? 💡

Insud Pharma operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.

Insud Pharma’s activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with 10,000 professionals in more than 50 countries, 20 industrial plants, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in over 110 countries worldwide. Insud Pharma believes in innovation and sustainable development.

We are looking for a GMP Quality Auditor to join our team in Madrid. Reporting to the GMP Quality Audit Regional Manager, this role will play a key part in performing global GxP quality audits and supporting the development of an effective global risk-based audit strategy and program.

What are we looking for? 💡

We are looking for a highly experienced professional with a strong background in GxP auditing within the pharmaceutical industry, able to lead complex global audits, assess risks in critical operations, and ensure full compliance with Insud Pharma’s quality procedures and applicable regulations.

The challenge! 💡

• Support the strategic development of an effective global risk-based audit strategy and program.

• Collect, collate, and incorporate relevant input into the audit strategy and planning process.

• Plan, lead, conduct, document, and follow up on GMP audits in accordance with Insud Pharma Quality procedures, applicable regulations, standards, quality agreements, and guidance documents.

• Take responsibility, when required, for more complex and higher-risk audits, including sterile API, aseptic DP, and combination products.

• Assess the risks associated with critical operations, ensuring a robust and consistent audit approach.

• Provide technical guidance on audit-related activities.

• Prepare audit reports in line with Insud Pharma Quality procedures and established timelines.

• Collaborate and communicate effectively with sites and reporting management regarding audit updates and execution.

• Ensure proper escalation to responsible management in the event of critical findings, and support immediate follow-up actions in accordance with Insud Pharma Quality procedures on escalation management and other relevant procedures.

• Ensure the proper definition and documentation of mitigation plans when applicable.

• Assess the adequacy of responses and CAPA plans related to audit findings in cooperation with stakeholder QA representatives and auditees.

• Ensure compliance of all activities and related documentation with applicable procedures.

• Review and advise on relevant policies and procedures.

• Ensure self-qualification and requalification activities according to applicable procedures.

• Maintain up-to-date knowledge of regulations, standards, and guidance documents.

• Identify and report best practices and lessons learned to support the development and training of GMP auditors.

• Report metrics as requested.

• Manage audit finding documentation and follow-up activities.

What do you need? 💡

• Education: Advanced University Degree in Chemistry, Pharmacy, Chemical Engineering, or a related field.

• Experience: Minimum 10–12 years of experience working in organizations regulated by GMP principles.

• Specific experience in a GxP auditing role.

• Technical knowledge:

  • Strong knowledge of EU and FDA regulations applicable to the Research & Development, Manufacturing, and Distribution of pharmaceutical products and raw materials.
  • Specific expertise in Quality Control / laboratory systems, including LIMS.
  • Solid understanding of applicable regulations, standards, quality systems, and guidance documents.
  • Ability to assess risks in complex and high-impact operations.

• Languages:

  • Excellent written and verbal communication skills in English.
  • Knowledge of Spanish will be considered a plus.

• Personal skills:

  • Ability to maintain objectivity and a consistent approach during audits.
  • Strong communication skills and the ability to create an environment that facilitates open communication.
  • High level of personal integrity.
  • Strong collaboration and stakeholder management skills in an international environment.

• Travel availability: Willingness to travel up to 70%.

What do we offer? 💡

• The opportunity to join a solid and growing international pharmaceutical company.

• A global role within a highly regulated and high-impact quality environment.

• Exposure to multicultural teams and international sites.

• A strategic position with visibility and responsibility in global audit activities.

• Ongoing professional development in a demanding, technical, and innovative environment.

• Competitive compensation package aligned with the experience and value you bring.

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EQUAL OPPORTUNITY COMMITMENT

At Insud Pharma, we are firmly committed to equal opportunities and to building a diverse and inclusive workplace. All applications will be considered regardless of gender, gender identity or expression, age, ethnicity, nationality, religion, sexual orientation, disability, or any other personal, physical, or social condition.