Hi, I'm kruti patel - Process Engineer- I at Strides Arcolab Limited
I am passionate about advancing pharmaceutical development through rigorous regulatory compliance and process innovation. I thrive in environments where analytical thinking and strategic planning lead to the successful launch of life-changing medicines.
At a glance
Curated signals on strengths, focus areas, and how they can help.
Interned at Sun Pharmaceutical Industries Ltd, gaining foundational regulatory and QA experience.
A Process Engineer at Strides Arcolab Limited, focusing on manufacturing operations and optimization.
Can help others by providing expertise in navigating complex US FDA regulatory submissions.
🚀 Career trajectory
Foundation in Pharma Quality & Regulation
Began career with an internship in Regulatory Affairs & Quality Assurance at Sun Pharmaceutical Industries Ltd, building foundational knowledge.
✦ Internship
✦ Regulatory Affairs
✦ Quality Assurance
Project Management & Compliance Specialist
Gained hands-on experience in project planning, management, and regulatory compliance at Time Cap Labs, Inc.
✦ Project Management
✦ Regulatory Compliance
✦ Pharmaceuticals
Process Engineering Focus
Currently applying engineering principles to manufacturing processes at Strides Arcolab Limited, focusing on process optimization.
✦ Process Engineering
✦ Manufacturing
✦ Strides Arcolab
💪🏻 Superpowers
Regulatory Navigation Expert
Expertise in guiding pharmaceutical products through complex regulatory pathways
✦ Proficient in IND, NDA, and ANDA submissions.
✦ Skilled in ensuring compliance with FDA, ICH, cGMP, GCP, and GLP.
✦ Experience with medical device regulations including 510(k) and PMA.
Process & Project Orchestrator
Driving efficiency and successful outcomes in manufacturing and development
✦ Managed projects from planning to execution, ensuring timely delivery.
✦ Experienced in process engineering and manufacturing operations.
✦ Adept at implementing corrective and preventive actions (CAPA) and root cause analysis.
Quality Assurance Guardian
Ensuring product integrity and adherence to stringent quality standards
✦ Ensured adherence to quality standards in pharmaceutical manufacturing.
✦ Experience with quality assurance documentation like BMR and APR.
✦ Maintained compliance with regulatory requirements for product recalls.
I'm excited about
✦ Exploring strategic partnerships to accelerate drug development pipelines.
✦ Seeking opportunities to contribute to innovative product launches and market access.
✦ Looking to connect with industry leaders for knowledge exchange and mentorship.
I can help with
✦ Can offer insights into navigating complex US FDA regulatory submissions.
✦ Provides expertise in optimizing pharmaceutical manufacturing processes.
✦ Assists with ensuring robust quality assurance and compliance frameworks.
I would love your help on
✦ Seeking guidance on emerging trends in biopharmaceutical innovation.
✦ Looking for connections with leaders in global regulatory strategy.
✦ Interested in mentorship regarding advanced drug delivery technologies.
