Executive/ Sr. Executive-Regulatory Affairs

Bhartia Management Consultancy
  • Bhiwadi
  • 2-4 lakh
  • 1-3 years
  • Views
  • 12 Jul 2017

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Key Responsibilities:
Coordination with different departments in plant.
Work as support for HO RA team.
Work as reviewer for different documents in plant for regulator prospective.
Knowledge of ICH guidelines, pharmacopoeia general chapters.
Functional knowledge of BMR, BPR, Specifications, Method of analysis, Stability protocols, Analytical method, Validation & Protocols review knowledge.
Knowledge of Stability guidelines, Specification guideline, Analytical method validation guideline.

Competency Skills:
Communication with good command in English, Good Networking skills
Highly dynamic, proactive and motivated, self-motivated, open minded
Good soft and analytical skills
Team player

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Bhartia Management Consultancy