Senior Auditor, GMP Auditing - Pharma (1140680)

Responsibilities

• Plans and executes quality audits to the defined company policies & standards, as well as in line with regulatory legal requirements and expectations.
• Works with the Quality, Operations, Supply Chain, Business Development, R&D and Legal to plan audits of GxP 3rd party manufacturers, material & service providers and company operational sites and units located throughout the globe as necessary.
• Handling and affording the necessary response to all company internal and external customers concerning audit related queries.
• Supporting Quality, Operations, Supply Chain, Business Development, R&D and Legal with Quality due diligence of potential new sterile and non-sterile suppliers and third-party manufacturers, and service providers via the conduct of associated support GxP audits.

Qualifications & Requirements

• Preferably B.Sc. or higher degree in pharmacy, life science, process engineering or similar.
• Thorough knowledge of pharmaceutical industry, quality systems, GMP and GDP, and good understanding of GCP, GVP and GLP requirements.
• Minimum of 5 years sterile auditing experience is required \(drug/combination products & medical device products\).
• Ability to travel 40-50% of time, primarily within the U.S. / North America.

Pay

$120,000.00 USD Annually - $135,000.00 USD Annually