Senior Technical Steward

6 days ago

Hyderabad Secunderabad Telangana Nizamabad Warangal, India beBeeProductSteward Full time ₹ 1,04,000 - ₹ 1,30,878
Job Overview

This is an opportunity to lead the stewardship of our products, ensuring robust product manufacturing and compliance with regulatory requirements.

  • Stewardship: We are seeking a professional who can ensure that all products manufactured at our platform or cluster are robust, with end-to-end technical oversight of product manufacturing processes throughout their commercial lifecycle.
  • The successful candidate will provide strong technical leadership to ensure that product and related packaging operations are maintained in compliance with current GMP and regulatory requirements.
  • They will also oversee and ensure the robustness and capability of manufacturing and packaging processes by monitoring each product's Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs).
  • Additionally, they will ensure the single point of contact for products within the site and across sites for multi-site products, as far as process technical issues are concerned.

Key Responsibilities:

  • Ensure that all manufacturing processes are robust and maintain compliance with current GMP and regulatory requirements.
  • Provide governance of the Manufacturing Robustness Review Board (MRRB).
  • Oversee and ensure the robustness and capability of manufacturing and packaging processes.
  • Monitor Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) through a continued process verification program and review of Annual Product Reviews (APRs).
  • Ensure the validation of all site products and maintain them in a constant state of validation throughout the product lifecycle.
  • Manage technical issues related to products within the site and across sites for multi-site products.
Requirements

This role requires a highly qualified individual with a minimum 15 years of experience in manufacturing, preferably with additional specialist experience in pharmaceutical formulation, process development, or manufacturing technology.

Essential qualifications include:

  • A Master's degree in Science, Pharmacy, or Chemical Engineering, or equivalent experience.
  • Ph.D. desirable.
  • Cross-cultural experience and strategic development skills are also essential.
Skills and Qualifications
  • Change Management
  • Manufacturing Process Science
  • Manufacturing Technologies
  • Npd (New Product Development)
  • Process Simulation
  • Project Management
  • Quality Compliance
  • R&D (Research And Development)
  • Technical Leadership

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