
Director of Quality Excellence
2 days ago
This is a senior leadership role that oversees the entire quality assurance function across R&D and pilot stages. As a leader, you will be responsible for ensuring first-time-right product designs are commercially viable and scalable.
Key Responsibilities:- Oversee developmental QA functions across JVL- R&D & Development Quality of new products, including DQA and Lab-Analytical assurance.
- Develop processes for new products at R&D and Pilot stages to pass through a robust stage gate system and ensure right first-time quality of products.
- Design experiments, DOE, and hypothesis studies to conduct experiments with R&D and Technology teams.
- Establish protocols for experiments, develop processes, study robustness, evaluate process performance between R&D to Pilot plant and site level.
- Promote technology transfer from R&D to Pilot plant and Site level, share relevant documents, and ensure QA-tech transfer to sites.
- Manage overall DQA and Kilo Lab operations, including budgeting, talent acquisition, and retention.
- Evaluate compliance with SOPs, Policies, standards, guidelines, regulatory requirements, and customer expectations.
- Develop in-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
- Study and enhance material flowability and free-flow characteristics of API/ingredients, powders, and supplements.
- Set up systems to analyze bulk density, compressibility, particle shape, particle size, and angle of repose.
- Implement strategies for particle size engineering, including micronization, granulation, and agglomeration.
- Conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
- Establish processes to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
- Expertly define and set process conditions, including RH for hygroscopic materials handling, packing configuration, and storage conditions to avoid lumping and agglomeration issues.
- Analyze complex data, identify process optimization opportunities, and implement analytical and problem-solving skills.
- 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 processes timely, review and sign-off of tech-pack, and release timely to sites.
- Prioritize tasks, manage timelines, and deliver results under tight deadlines using strong project management skills.
- Generate monthly, weekly, and periodic DQA reports, review them with management, and apprise quality-related issues in new projects along with areas of improvement.
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