Analista de Qualidade Sênior

Responsibilities may include the following and other duties may be assigned.

 

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
  • thereby fostering the achievement of company's mission globally.
  •  Inspect, approve / reject products outside the quality specifications.
  • Perform activities related to product demonstration and product samples.
  • Register, Treat and Analize Nonconformities found in Quality Operations and 3PL (CAPA).
  •  Controlling overdue and nonconforming products.
  • Provide support and follow-up of projects that involve Quality Operations;
  •  Validate, Control and Archive SGQ documents;

 

Basic Qualifications:

  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • Bachelor's Degree in areas related to health (Pharmacy, Biomedicine)
  • Advanced English, good speaking, reading and writing
  • Preferable experience and/or certification on continuous improvement field (six sigma, kaizen, etc)
  • Experience in the Quality area of pharmaceutical or health products companies;
  • Experience in environments regulated by RDC 16/13.
  • ISO standards knowledge, especially on ISO 13485 standar
  • Solid software proficiency in: MS Office, including PowerPoint, Excel and Word
  • Demonstrate ability to handle multiple tasks accurately and efficiently
  • Demonstrate negotiation skills
  • Results Oriented
Type

Corporate / senior

North America

Goleta , United States

Location

United States

Goleta

Type

Corporate / senior