Quality Assurance Director

Quality Assurance Director

The company is committed to offering high-quality and innovative life science ingredients to enrich all forms of life.

As a Group Leader for Developmental Quality Assurance, you will lead quality systems across R&D and pilot stages, ensuring first-time-right, scalable product designs.

Key responsibilities include experimental design, process development, technology transfer, lab and budget management, regulatory compliance, and advanced material characterization.

• 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.
• Management of overall DQA & Kilo Lab budget – Capex, opex, hiring and retention of talent.
• 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.

M. Sc /M.Pharma– Chemistry

16-24 Years of experience in API/Intermediate/Fine chemical Industry.

Sound knowledge of Fine chemical, DQA is must with good knowledge of product development at R&D stage.

Opportunity to work with a global integrated Life Science products and Innovative Solutions provider.

Competitive salary and benefits package.

Career growth opportunities in a rapidly evolving industry