
Senior Quality Assurance Manager
2 weeks ago
We are seeking a skilled professional to assume the role of Associate Director-Quality Assurance, responsible for leading quality systems across R&D and pilot stages.
This position entails ensuring first-time-right, scalable product designs through experimental design, process development, technology transfer, lab management, regulatory compliance, and advanced material characterization.
- Key responsibilities include:
- Developing and implementing quality assurance strategies to ensure developmental quality functions across JVL-R&D & Development Quality.
- Designing and executing experiments, DOE, hypothesis studies to conduct R&D and Technology team experiments.
- Creating and evaluating process protocols for experiments, developing processes, studying robustness, and evaluating process performance between R&D to Pilot plant and site level.
- Leading technology transfer from R&D to Pilot plant and Site level, sharing relevant documents, and ensuring QA-tech transfer to sites.
- Managing overall DQA & Kilo Lab budgets, hiring and retention of talent.
- Ensuring compliance with SOPs, policies, standards, guidelines, regulatory, and customer requirements.
- Providing in-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
- Studying and improving material flowability and free-flow characteristics of API/ingredients, powders, and supplements.
- Establishing a system to analyze and enhance bulk density, compressibility, and particle shape, particle size of materials, angle of repose.
- Implementing strategies for particle size engineering, including micronization, granulation, and agglomeration.
- Designing to conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
- Setting up a process to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
- Expertise 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.
- Ensuring smooth technology transfer of crystallization and powder processing technologies.
- Coordinating 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.
- Monthly, weekly, and periodic DQA reports generation and review with management, apprising the quality-related issues in new projects with areas of improvement.
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