Senior Quality Assurance Manager
24 hours ago
As a Senior Quality Assurance Manager, you will be responsible for leading quality systems across R&D and pilot stages. Your key responsibilities include experimental design, process development, technology transfer, lab and budget management, regulatory compliance, and advanced material characterization.
Key Responsibilities:- Overall responsible for developmental Quality Assurance function across the JVL-R&D & Development Quality of new products.
- Setting-up processes for new products at R&D and Pilot stage to pass through a robust stage gate system and ensure right first-time quality of products are designed.
- Designing right experiments, DOE, hypothesis studies to conduct experiments with R&D and Technology teams.
- Designing right protocols for experiments, developing processes, studying robustness, evaluating process performance between R&D to Pilot plant and site level.
- Playing a key role in technology transfer from R&D to Pilot plant and Site level, sharing right documents, and ensuring QA-tech transfer to sites.
- Managing overall DQA & Kilo Lab budgets, including Capex, Opex, hiring, and retention of talent.
- Ensuring compliance of SOPs, Policies, standards, guidelines, regulatory, and customer requirements.
- Having 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 APIs/ingredients, powders, supplements.
- Setting up systems 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 processes to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
- Being an 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.
- Having 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 processes in the system timely, reviewing, and signing off tech-pack, and releasing timely to sites.
- Having strong project management skills, with the ability to prioritize tasks, manage timelines, and deliver results under tight deadlines.
- Generating monthly, weekly, and periodic DQA reports with management review and appraisal of quality-related issues in new projects with areas of improvement.
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