Quality Assurance Expert

2 days ago

Kollam, Kerala, India beBeeQuality Full time ₹ 1,80,00,000 - ₹ 2,40,00,000
Job Overview

We are seeking a seasoned professional to take on the role of Associate Director-Quality Assurance. This is an exceptional opportunity for someone who is passionate about ensuring the highest standards of quality in product development.

Responsibilities
  • Lead the Quality Assurance function across R&D, focusing on developmental quality and lab-analytical assurance.
  • Establish a robust stage gate system to ensure new products meet quality standards before commercialization.
  • Collaborate with R&D and Technology teams to design experiments, DOE, hypothesis studies, and conduct analysis.
  • Develop processes, study robustness, and evaluate performance between R&D and Pilot plant sites.
  • Play a key role in technology transfer from R&D to Pilot plant and Site level, sharing relevant documents and ensuring QA-tech transfer to sites.
  • Manage the overall DQA & Kilo Lab budget, including Capex, Opex, hiring, and talent retention.
  • Ensure compliance with SOPs, Policies, standards, guidelines, regulatory, and customer requirements.
  • Pursue in-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
  • Study and improve material flowability and free-flow characteristics of API/ingredients, powders, supplements.
  • Set up a system to analyze and enhance bulk density, compressibility, and particle shape, particle size of materials, angle of repose.
  • Implement strategies for particle size engineering, including micronization, granulation, and agglomeration.
  • Design to conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
  • Set up a process to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
  • Expert in defining and setting process conditions, including RH for Hygroscopic materials handling, their packing configuration, and storage conditions to avoid lumping and agglomeration issues.
  • Strong analytical and problem-solving skills, including ARD, (Analytical/QC/instruments knowledge) with the ability to analyze complex data and identify process optimization opportunities.
  • Ensure smooth technology transfer of crystallization and powder processing technologies.
  • Coordinate with Business, Technology absorption cell, site QA, and internal CFTs to ensure smooth functioning, closing of stage gate process in the system timely, review, and sign-off of tech-pack, and release timely to site.
  • Strong project management skills, with the ability to prioritize tasks, manage timelines, and deliver results under tight deadlines.
  • Generate and review monthly, weekly, and periodic DQA reports with management and apprise the quality-related issues in new projects with areas of improvement.

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