Quality Assurance Manager

3 days ago

Vadodara, Gujarat, India beBeeQualityAssuranceManager Full time ₹ 1,00,00,000 - ₹ 1,50,00,000

Job Overview

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  • This is a key role that oversees the development and implementation of quality assurance processes across the organization.
  • The position involves setting up stage gate systems to ensure the right-first-time quality of products, which are commercially viable and scalable.
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Responsibilities:

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  1. ">
  2. Develop and implement robust stage gate systems for new product development and pilot stages.">
  3. Design and conduct experiments with the R&D and Technology teams using techniques such as DOE and hypothesis studies.">
  4. Evaluate process performance between R&D and Pilot plant levels, and design protocols for experiments.">
  5. Play a key role in technology transfer from R&D to Pilot plant and site levels, ensuring smooth handovers and QA tech transfer.">
  6. Manage the overall budget for DQA and Kilo Lab, including capex, opex, hiring, and talent retention.">
  7. Ensure compliance with SOPs, policies, standards, guidelines, regulatory requirements, and customer needs.">
  8. Demonstrate expertise in crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.">
  9. Analyze and improve material flowability and free-flow characteristics of API/ingredients, powders, and supplements.">
  10. Set up systems to analyze bulk density, compressibility, and particle shape, size, and angle of repose.">
  11. Implement strategies for particle size engineering, including micronization, granulation, and agglomeration.">
  12. Conduct advanced physical characterization of APIs and ingredients, including particle size distribution, morphology, porosity, and surface area analysis.">
  13. Utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.">
  14. Expertly define and set process conditions, including RH for hygroscopic materials handling, packing configuration, and storage conditions to avoid lumping and agglomeration issues.">
  15. Strong analytical and problem-solving skills, with the ability to analyze complex data and identify process optimization opportunities.">
  16. Ensure smooth technology transfer of crystallization and powder processing technologies.">
  17. Coordinate with business, technology absorption cell, site QA, and internal CFTs to ensure smooth functioning, closing of stage gate processes, and timely review and sign-off of tech-packs and releases.">
  18. Strong project management skills, with the ability to prioritize tasks, manage timelines, and deliver results under tight deadlines.">
  19. Generate monthly, weekly, and periodic DQA reports, reviewing them with management and highlighting quality-related issues and areas for improvement.">
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