Location: Morristown, NJ, US
Salary: $120,000.00 USD Annually - $135,000.00 USD Annually
Description: Our client is currently seeking a Senior Auditor, Auditing who will be responsible to organize, conduct and manage independent and objective quality audits (including for cause audits) of all company GxP suppliers and third party manufacturers (sterile and non-sterile), and service providers that have a GxP impact (drug product, combination product & medical device related), as well as undertaking corporate quality audits of manufacturing sites and operational units and support organizations with GxP impact, (excluding GCP & PV audits).
This Job Will Have The Following 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.
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact: [email protected]
This job and many more are available through The Judge Group. Find us on the web at www.judge.com