
Senior Quality Systems Manager
4 days ago
Jubilant Ingrevia Limited is a global integrated Life Science products and Innovative Solutions provider serving Pharmaceutical, Nutrition, Agrochemical, Consumer and Industrial customers with our customised products and solutions that are innovative, cost-effective and conforming to excellent quality standards.
We have 5 world-class manufacturing facilities i.e. One in UP at Gajraula, Two in Gujarat at Bharuch and Savli, Two in Maharashtra at Nira and Ambernath. Our business is split across 3 business verticals, with global leadership across our key product lines.
Key Responsibilities:- Overall responsible for developmental Quality Assurance function across the JVL- R&D & Development Quality of the new product, includes DQA & Lab – Analytical assurance.
- Setting–up a process 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, which are commercially viable and scalable.
- Design right experiments, DOE, hypothesis study to conduct experiments with R&D and Technology team.
- Design right protocols for experiments, development of a process, study robustness, evaluate process performance between R&D to Pilot plant and site level
- Play key role in technology transfer from R&D to Pilot plant and Site level, share right documents and ensure QA – tech transfer to sites.
- Ensure compliance of SOPs, Policies, standard, guideline, regulatory and customer requirement
- In-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
- Study and improve the material flowability and free-flow characteristics of API / ingredients, powders, Supplement
- Set-up a system to Analyse and enhance the bulk density, compressibility, and particle shape, particle size of materials, angle of repose.
- Implement strategies for particle size engineering, including micronization, granulation, and agglomeration.
- Design to Conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
- Set-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 the ability to analyse complex data and identify process optimization opportunities.
- 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 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 and apprise the quality related issues in new projects with areas of improvement.
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