Quality Assurance Professional

Job Opportunity

We are seeking an experienced professional to lead our quality assurance function across research and development stages. As a key team member, you will be responsible for ensuring the successful implementation of developmental quality assurance processes through experimental design, process development, technology transfer, laboratory management, regulatory compliance, and advanced material characterization.

Main Responsibilities

• Overall accountable for developmental Quality Assurance function across the R&D & Development Quality of new products, including DQA & Laboratory Analytical Assurance.
• Establishing a process 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 designed are commercially viable and scalable.
• Designing experiments, DOE, hypothesis studies to conduct experiments with R&D and Technology teams.
• Developing protocols for experiments, process development, studying robustness, evaluating process performance between R&D and Pilot plant and site levels.
• Playing a key role in technology transfer from R&D to Pilot plant and Site levels, sharing relevant documents and ensuring QA-technology transfer to sites.
• Managing overall DQA & Kilo Lab budget, Capex, Opex, talent hiring and retention.
• Ensuring compliance with SOPs, Policies, Standards, Guidelines, Regulatory Requirements, and Customer Specifications.

Necessary Skills and Qualifications

• 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, Supplement 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 and conducting 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 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 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.
• Generating and reviewing monthly, weekly, and periodic DQA reports with management and apprising the quality-related issues in new projects with areas of improvement.

What We Offer

• An opportunity to work in a rapidly evolving industry with competitive salary and benefits package.
• Career growth opportunities in a dynamic environment.