Chief Product Quality Engineer

4 days ago

Dombivli, Maharashtra, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,25,00,000
Job Title

Overview:

We are seeking an accomplished Quality Assurance Professional to lead our developmental Quality Assurance function across the entire product lifecycle.

Key Responsibilities:

  • Develop and implement a robust stage gate system for new products at the R&D and Pilot stages, ensuring right-first-time quality and commercial viability.
  • Design and execute experiments, DOE, and hypothesis studies with the R&D and Technology teams to optimize product development.
  • Establish protocols for experiments, develop processes, and evaluate performance between R&D and Pilot plants.
  • Drive technology transfer from R&D to Pilot plants and sites, sharing relevant documents and ensuring QA compliance.
  • Manage the DQA & Kilo Lab budget, including Capex, opex, talent acquisition, and retention.
  • Maintain compliance with SOPs, policies, standards, regulatory requirements, and customer demands.
  • Utilize in-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
  • Analyze and enhance material flowability and free-flow characteristics of APIs, ingredients, powders, and supplements.
  • Set up a system to analyze and improve bulk density, compressibility, and particle shape, particle size of materials, angle of repose.
  • Implement strategies for particle size engineering, including micronization, granulation, and agglomeration.
  • Conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
  • Establish a process to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
  • Determine process conditions, including RH for Hygroscopic materials handling, packing configuration, and storage conditions to avoid lumping and agglomeration issues.
  • Possess strong analytical and problem-solving skills, including ARD, (Analytical/QC /instruments knowledge), to analyze complex data and identify process optimization opportunities.
  • Ensure smooth technology transfer of crystallization and powder processing technologies.
  • Collaborate with Business, Technology absorption cell, site QA, and internal CFTs to ensure timely closure of stage gate processes, review and sign-off of tech-packs, and release to sites.
  • Prioritize tasks, manage timelines, and deliver results under tight deadlines, leveraging strong project management skills.
  • Generate monthly, weekly, and periodic DQA reports for management review and appraisal of quality-related issues in new projects with areas of improvement.

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