Quality Auditor (Pharmaceutical, Contract, Remote - Germany)

Job summary

This role involves conducting supplier quality audits within the pharmaceutical and medical device sectors, primarily in Germany and neighboring countries. The position offers flexibility in accepting assignments based on personal availability.

Qualifications

• Minimum of 5 years of practical audit experience in pharmaceutical, medical device, or biologics industries.
• Experience as the lead auditor in at least 10 audits.
• Direct audit knowledge of 21 CFR part 210/211, EU Vol 4, ISO 13485, and 21 CFR 820.
• Strong communication and writing abilities.
• Proven skills in conflict resolution.
• Adaptability to new technologies and software.
• Willingness to travel regionally.

Responsibilities

• Conduct supplier audits at various locations within the designated region.
• Ensure quality assurance in supply chains for clients in the pharmaceutical, medical device, cosmetics, biologics, and animal health sectors.
• Plan, execute, and report on audits according to client and personal schedules.
• Utilize regulatory knowledge of relevant standards during audits.
• Respond promptly to inquiries from the Content team regarding audit reports.

Skills

• Strong communication and writing skills.
• Ability to effectively manage and deescalate conflicts.
• Proficiency in adapting to new technologies and software.

Education

• ISO certifications are preferred but not mandatory.

Tools

• Familiarity with regulatory standards such as ISO, CFR, and FDA guidelines.