Healthcare Analyst Manager

4 days ago

Thāne, Maharashtra, India beBeeAnalytical Full time ₹ 9,00,000 - ₹ 12,00,000

Seeking a Manager Healthcare professional to lead Analytical method validation end-to-end activities, supporting respective documentation for various regulatory markets. The successful candidate will plan daily tasks and ensure quality management system execution.

About the Role:

The Manager Healthcare role is responsible for managing daily activities in Analytical method validation, ensuring compliance with GLP, regulatory, and quality expectations. This includes reviewing documents through the DMS system and following QMS guidelines.

Key Responsibilities:

  • Plan and execute daily activities for Analytical method validation.
  • Ensure quality management system execution during validation activity.
  • Impart training to AMV personnel as required.
  • Support CMO's projects for timely completion.
  • Update documents according to regulatory requirements.
  • Handle regulatory query data generation and response.
  • Provide technical input for analytical data generation.
  • Address plant analytical issues and provide support.
  • Deliver technical training to team members.

Requirements:

  • M. Pharm or M. Instrument degree.
  • Knowledge of HPLC, GC, KF, IC, PSD, etc.
  • Exposure to US, UK, EU, ROW regulatory bodies.
  • Understanding of GDP to meet regulatory requirements.
  • Familiarity with handling regulatory queries.
  • Ability to work flexible shifts based on project requirements.
  • Capacity to visit external sites as needed.

What We Offer:

This opportunity provides a chance to work in a dynamic environment, contributing to the success of our organization. As a Manager Healthcare professional, you will have the opportunity to develop your skills and expertise while making a meaningful impact.

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