Senior Compliance Specialist

hace 4 días

Ciudad de México, Ciudad de México Kenvue A tiempo completo

Quality Assurance Specialist

This position is part of the LatAm Franchise Quality organization and is responsible for the quality & compliance oversight for the SelfCare Franchise during all the Product Lifecycle.

Key Responsibilities:

  • Participate in local and regional quality/compliance projects and act as the Quality voice for New Product Introduction and New Business Development in LATAM for Consumer OTC segment.
  • Provide risk based analysis of Quality aspects related to New Product Introduction and New Business Development
  • Understands current and emerging regulations and impact to quality of OTC keeping affiliates/EM located in other regions updated and compliant on new regulations.
  • Partner with adjacent areas of the business to build a robust strategy to achieve the committed goals.
  • Act as a critical voice for opportunities identified in the evaluation of the follow up studies.
  • Ensures all products meet and/or exceed company and local government standards evaluating regulations to provide risk analysis guidance and make decisions about GxP activities accurately.
  • Conducts and tracks quality investigations and process deviations and follows up to ensure corrective action has been taken.
  • Develop & qualify new/current service provider/supplier External Service Providers in order to attend regulations and Kenvue requirements.

Requirements:

  • Bachelor's Degree in Pharmacy, Chemistry, Engineering or related science is required. Pharmacy is preferred.
  • Proven experience of at least 6 - 8 years in a regulated industry. Pharmaceutical Industry is preferred.
  • Knowledge in Drug Product Manufacturing and Controls.
  • Knowledge on regulatory requirements across LatAm region such as ANVISA, COFEPRIS, INVIMA, ANMAT.
  • Working knowledge of CAPA, Change Control, and General Quality Systems process.
  • Advanced knowledge of Microsoft Office (Excel, Power Point, Word).
  • Advanced to Fluent English.
  • Fluent in Spanish.

What's In It For You:

  • Competitive Benefit Package
  • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
  • Learning & Development Opportunities
  • Employee Resource Groups

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