Senior Auditor, GMP Auditing - Pharma (1140680)
$120k - $135kThe Judge Group
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. 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. Contact: View email address on click.appcast.io #J-18808-Ljbffr The Judge Group
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$135k - $142k
...independent and objective quality audits (including for cause audits)... ...interacts with Managers, Senior Managers, Directors and Sr. Directors... ...of other corporate quality auditors and assigned Subject Matter... ...pharmaceutical industry, quality systems, GMP and GDP, and good...SeniorContract workWork experience placementWork at officeFlexible hours- Norwich Pharmaceuticals is seeking a Quality Auditor to conduct and manage GxP audits for suppliers and manufacturers. The role requires extensive experience in pharmaceutical quality systems, compliance with U.S. FDA and European regulations. The ideal candidate has a...Senior
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