Senior Director Quality Engineering

2 weeks ago

Vijayawada, Andhra Pradesh, India beBeeQuality Full time ₹ 15,12,000 - ₹ 21,60,000
Job Summary

We are seeking a highly skilled Quality Assurance leader to spearhead quality systems across R&D and pilot stages, ensuring first-time-right product designs.

Key Responsibilities
  • Promote quality excellence in the developmental quality assurance function, encompassing DQA & Lab – Analytical assurance.
  • Develop and implement process frameworks for new products at R&D and Pilot stages to guarantee right-first-time quality.
  • Create strategic experimental designs, DOE, hypothesis studies to conduct experiments with R&D and Technology teams.
  • Design robust protocols for experiments, process development, and study performance between R&D and Pilot plant levels.
  • Lead technology transfer from R&D to Pilot plant and Site levels, sharing relevant documents and ensuring QA-tech transfer to sites.
  • Manage overall DQA & Kilo Lab budgets, Capex, opex, talent hiring, and retention.
  • Ensure compliance with SOPs, Policies, standards, regulatory requirements, and customer needs.
  • Maintain 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 API / ingredients, powders, supplements.
  • Establish systems for analyzing bulk density, compressibility, particle shape, particle size, and 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.
  • Utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
  • Determine optimal process conditions, including RH for Hygroscopic materials handling, packing configuration, and storage conditions to prevent lumping and agglomeration issues.
  • Show strong analytical and problem-solving skills, including ARD, Analytical/QC instruments knowledge, to analyze complex data and identify process optimization opportunities.
  • Guarantee smooth technology transfer of crystallization and powder processing technologies.
  • Collaborate with Business, Technology absorption cell, site QA, and internal CFTs to ensure smooth functioning, closing of stage gate processes timely, review and sign-off of tech-packs, and release to sites.
  • Exhibit strong project management skills, prioritizing tasks, managing timelines, and delivering results under tight deadlines.
  • Generate monthly, weekly, and periodic DQA reports, reviewing them with management and highlighting quality-related issues in new projects with areas for improvement.

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