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External Supply Quality Management Specialist – Pharmaceutical

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Are you passionate about solving tough challenges? In this role you will use your quality assurance skills to find creative solutions for consumers everyday problems! If this sounds like fun, we would love to hire someone with your skills and abilities to join our Quality Assurance organization.

GENERAL RESPONSIBILITIES INCLUDE:

We are looking for hard-working and driven individuals who can:

  • Local GTM responsibility such as leading and handling programs, capabilities and executional/operational issues that span across the plants in the market

  • Responsible for related quality and regulatory requirements

  • Scope could include marketed products (i.e., from start of production) and can involve the supply chain through storage, distribution and customization

  • Local GTM QA also supports Regional QA on investigations and remediations associated with customization and distribution

  • Ensuring products delivered by our External Manufacturing partners meet consumer and customer expectations, are produced according to applicable P&G policies/procedures, and meet or exceed regulatory requirements for drug products, medical devices and cosmetics.

  • Understand and ensure all GMP requirements and regulations are met for all aspects of production

  • This role entails management of multiple highly supervised external manufacturing sites making and packing new products

  • The successful candidate will own 2 contract manufacturing (CM) sites, with on-site visits required

  • Regulatory & Compliance – based on risk profile, understand, mentor, and complete CM compliance to: Industry quality standards (i.e. ISO, CFR), cGMP requirements, P&G quality systems, Quality Agreements or Applicable P&G SOP’s

  • Initiative and New Project support – validations, new site start-ups

  • Collaboration with the CM’s to complete on time and compliant Annual Product Quality Reviews

  • Participation in shelf quality audits, and collaborate with cross-functional teams to identify areas to amplify consumer delight


Qualifications

Required:

  • 3+ years of related experience in the pharmaceutical industry
  • Bachelor’s degree in Pharma, Biology or Chemistry
  • Experience within QA Systems - Veeva, Enovia
  • Good practices during fabrication

Preferred:

  • GMP knowledge
  • Desired experience with Contract Manufacturing
  • Spanish communication skills
Job locations:
São Paulo, São Paulo, Brazil
Job Type: Full time Job categories: Quality Assurance Req No: R000069098
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