GMP Quality Assurance Auditor — Hybrid & Growth

Placements24; O Mente; Hybrid; EUR 45,000 - 60,000; Full time

Benefits offered by this job

Hybrid work

Competitive salary

Bonuses

Health, dental, vision insurance

Retirement plan

Professional development

Job summary

Placements24 seeks an experienced Pharmaceutical Quality Assurance Auditor to join our client in Queenstown. The role focuses on conducting GMP audits, identifying improvements, and driving CAPA implementation to safeguard product quality and patient safety.

You will audit internal operations, supplier and contract manufacturers, and collaborate with cross-functional teams to ensure compliance with cGMP and ICH guidelines in a hybrid work environment.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related scientific field.
• Minimum of 4 years of experience in pharmaceutical QA or QC.
• Proven experience in conducting GMP audits.
• In-depth knowledge of pharmaceutical regulations (e.g., cGMP, ICH guidelines).
• Strong analytical, critical thinking and problem-solving skills.
• Excellent report writing and communication abilities.

Responsibilities

• Plan and conduct internal audits of GMP-regulated operations, including manufacturing, quality control, and warehousing.
• Perform external audits of suppliers and contract manufacturing organizations to ensure compliance.
• Review audit findings, prepare detailed audit reports, and present them to management and auditees.
• Follow up on corrective and preventive actions (CAPAs) to ensure their effective implementation.
• Stay current with evolving regulatory requirements and industry best practices in quality assurance.
• Contribute to the continuous improvement of the Quality Management System (QMS).

Skills

GMP audits

Analytical thinking

Report writing

Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Job description

Placements24 seeks an experienced Pharmaceutical Quality Assurance Auditor to join our client in Queenstown. The role focuses on conducting GMP audits, identifying improvements, and driving CAPA implementation to safeguard product quality and patient safety.

You will audit internal operations, supplier and contract manufacturers, and collaborate with cross-functional teams to ensure compliance with cGMP and ICH guidelines in a hybrid work environment.