Pharmaceutical Quality Assurance Auditor

Placements24; O Mente; Híbrido; EUR 45 000 - 60 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work

Competitive salary

Bonuses

Health, dental, vision insurance

Retirement plan

Professional development

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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).

Conhecimentos

GMP audits

Analytical thinking

Report writing

Communication

Formação académica

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

Descrição da oferta de emprego

About the Role

Our client is seeking a vigilant and experienced Pharmaceutical Quality Assurance Auditor to join their team in Queenstown . This role is pivotal in ensuring that our pharmaceutical operations consistently meet and exceed stringent quality standards and regulatory requirements. You will conduct internal and external audits, identify areas for improvement, and work collaboratively with departments to implement corrective actions. This position offers a challenging and rewarding career path for an individual dedicated to maintaining the highest levels of quality and compliance in the pharmaceutical industry, contributing to patient safety and product integrity.

Key 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).

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4 years of experience in pharmaceutical Quality Assurance or Quality Control.
• 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.

Benefits

• Competitive annual salary and potential for bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan.
• Opportunities for professional development and training.
• A hybrid work environment offering a balance between office-based work and remote flexibility.
• The opportunity to ensure the highest standards of quality in a vital sector in Queenstown .