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Sr. Lead QA Auditor

  • Job type: Permanent
  • Location: Parsippany-Troy Hills, New Jersey
  • Salary: Negotiable
  • Job reference: 271671/009_1555369434
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 15/04/2019

Sr. Lead QA Auditor

Northern, NJ

A large global leader in pharmaceuticals is looking for Sr. Lead QA Auditor to join their rapidly expanding team! This company has an established presence in pharma, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. If you are looking to get in with a well-established pharmaceutical leader than please don't hesitate to apply.

The Sr. Lead QA Auditor will have the following responsibilities:

  • You will perform GMP/GDP audits of pharmaceutical manufacturing, packaging/ labeling, laboratory controls, technical services, storage & distribution and quality systems for sterile/non-sterile APIs, drug products, medical devices, combination products, packaging materials and services.

  • GMP/GDP audits are normally take place in the Americas on behalf of company sites and business partners worldwide.

  • Audit scope includes external Vendor audits and internal Corporate Quality audits of company sites .You Will also insure sites have robust inspection readiness plans in place to insure smooth regulatory agency inspections and successful product launches.

The ideal candidate will have:

  • Minimum 4 years' experience as a Quality Auditor in a regulated pharmaceutical environment with a minimum of 65 audits performed in a Lead Auditor role

  • Strong working knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

  • Experience with a regulatory authority, e.g., FDA is desirable but not required

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