Gdp Auditor

Position Overview: As a Consulting Compliance Auditor, you will play a critical role in ensuring that our pharmaceutical client adheres to WHO guidelines for Good Distribution & Storage Practices, with a particular emphasis on shipping, cold chain management, and storage of pharmaceutical products. Our clients maintain various storage environments, including refrigeration storage, ambient storage, and DEA storage, making it crucial for the auditor to have expertise in all these areas.

Key Responsibilities:

1. Conduct Onsite Audits: Visit client facilities and conduct comprehensive audits of their pharmaceutical storage and distribution processes, including shipping, cold chain, and general storage areas.

Assess Compliance: Evaluate and assess compliance with WHO guidelines for Good Distribution & Storage Practices, ensuring that all applicable regulations are met.

Identify Deficiencies: Identify and document any deficiencies or non-compliance issues during the audit process. This includes deficiencies related to facility design, temperature control, storage conditions, security, and documentation.

Audit Checklist: Utilize a thorough audit checklist specifically designed to capture WHO regulations and guidelines, ensuring that all relevant aspects are evaluated.

Reporting: Prepare detailed audit reports that clearly outline findings, deficiencies, and recommendations for corrective actions. These reports should be presented to clients in a clear and concise manner.

Client Interaction: Work closely with clients to discuss audit results, provide guidance on compliance improvements, and address any questions or concerns they may have.

Continuous Learning: Stay updated on evolving pharmaceutical industry regulations, WHO guidelines, and best practices to ensure the audit process remains current and effective.

Qualifications:

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, or a related field. A relevant master's degree is a plus.

Minimum of 8 years of experience in pharmaceutical industry auditing, with a strong focus on Good Distribution & Storage Practices.

Expertise in WHO guidelines for Good Distribution & Storage Practices, particularly in shipping, cold chain, and storage of pharmaceutical products.

Familiarity with refrigeration storage, ambient storage, and DEA storage practices.

Excellent attention to detail and analytical skills.

Strong communication and interpersonal skills.

Ability to travel to client sites for onsite audits (up to 50% travel).

Preferred Qualifications:

• Certification in pharmaceutical auditing or regulatory affairs.

Experience working with a variety of pharmaceutical companies, including small and large-scale operations.

Knowledge of other international pharmaceutical regulations (e.g., FDA, EMA) is a plus.