Developmental Quality Assurance Lead
3 days ago
Quality Assurance Professional
About the RoleWe are seeking an experienced Quality Assurance expert to lead our developmental quality assurance function across research and development stages.
The successful candidate will be responsible for ensuring high-quality, scalable product designs, and collaborating cross-functionally to close stage gates, support analytical needs, and drive timely outcomes.
Key Responsibilities- Overall responsible for developmental Quality Assurance function across R&D & Development Quality of new products.
- Establishing a process for new products at R&D and pilot stage to pass through a robust stage gate system.
- Designing experiments, DOE, hypothesis study to conduct experiments with R&D and Technology teams.
- Designing protocols for experiments, development of processes, study robustness, evaluate process performance between R&D to Pilot plant and site level.
- Playing key role in technology transfer from R&D to Pilot plant and Site level, share relevant documents and ensure QA-tech transfer to sites.
- Ensuring compliance of SOPs, policies, standards, guidelines, regulatory, and customer requirements.
- Expertise in 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 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.
- 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 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 ability to prioritize tasks, manage timelines, and deliver results under tight deadlines.
- Generating monthly, weekly, and periodic DQA reports and reviewing with management and apprising the quality-related issues in new projects with areas of improvement.
- Opportunity to work on cutting-edge technologies in the chemical sector.
- Competitive salary and benefits package.
- Career growth opportunities in a rapidly evolving industry.
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