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Remediation Consultants, Mexico

hace 5 meses

Guadalajara, Jalisco, México Pharmatech Associates A tiempo completo
Pharmatech Associates is seeking international consultants to perform Remediation Project work for clients manufacturing facilities located in Mexico

Typical Project Responsibilities include:

  • Remediation of a company's QMS against US FDA requirements with the aim of helping our clients pass a preapproval inspection in support of ANDA, NDAs, and BLA submissions and providing prioritized remediation recommendations
  • Evaluation of inspection readiness programs, including providing recommendations for improvement
  • Remediation planning for various dosage form manufacturing facilities, including oral solid, liquid, and other nonsterile, as well as sterile, dosage forms
  • Remediation of laboratory control systems
  • Participate in complex root cause investigations, including manufacturing deviations and OOS investigations
    Educational/Experience Requirements include:
  • B.S. in life sciences and 10 years' of relevant experience
  • Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients
  • Expert knowledge of current laws, regulations, and related to gaining approval for manufacturing drug products for the US market
  • Bilingual is required in both Spanish and English
  • Ability to work with a team of consultants and manage work to a defined scope of work and meet timelines
  • Superb written and oral communication skills
  • Excellent interpersonal and soft skills
  • Ability to solve problems using innovative techniques
  • Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law._