QA Risk Analysis/Assesment Expert

  • Full-time

Company Description

Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

Support the QA Operation in the areas of FMEA, Audits, Risk Analysis and Risk Assessment.  Must have experience in aseptic manufacturing and have extensive knowledge in QA Systems. 

Qualifications

  • Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology.
  • Minimum of  3 years of experience in the parenteral or biotechnology industry. 
  • REQUIRED Experience in manufacturing operations of Parenteral Products Manufacturing.
  • Strong knowledge of relevant CAPA, GMP, FDA, EU regulations and the ability to interpret and apply them for intended use. 
  • Fully bilingual (Spanish/English) communication skills, both written and verbal are required.
  • Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results.
  • Knowledge of problem solving and root cause analysis methodologies.
  • Experience in Batch Record Review, parenteral products and QA.

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.