Hi, I'm kruti patel - Process Engineer- I at Strides Arcolab Limited
I am a driven regulatory and process professional passionate about bringing safe and effective medicines to patients. I thrive in dynamic environments where analytical thinking and meticulous execution are key to navigating complex pharmaceutical development and manufacturing challenges.
At a glance
Curated signals on strengths, focus areas, and how they can help.
Managed complex regulatory submissions including INDs, NDAs, and 510(k)s at Sun Pharmaceutical Industries.
Driving process efficiencies as a Process Engineer in pharmaceutical manufacturing at Strides Arcolab Limited.
Can help others by navigating complex regulatory pathways and ensuring product compliance.
🚀 Career trajectory
Foundation in Quality and Compliance
Began career with internships and roles focused on quality assurance, regulatory compliance, and good practices at Sun Pharmaceutical Industries and Time Cap Labs.
✦ Quality Assurance
✦ Regulatory Compliance
✦ Internship
Project Management and Regulatory Specialist
Transitioned to roles involving Assistant Project/Planning Management and specialized as a Regulatory Compliance Specialist at Time Cap Labs, deepening expertise.
✦ Project Planning
✦ Regulatory Affairs
✦ Compliance
Process Engineering in Pharmaceutical Manufacturing
Currently applying engineering principles to optimize processes and contribute to manufacturing excellence at Strides Arcolab Limited.
✦ Process Engineering
✦ Manufacturing
✦ Pharmaceuticals
💪🏻 Superpowers
Navigating Regulatory Landscapes
Expertise in pharmaceutical and medical device regulations.
✦ Managed regulatory submissions including INDs, NDAs, and 510(k)s.
✦ Ensured compliance with cGMP, GCP, and GLP standards.
✦ Developed and implemented SOPs for quality assurance processes.
Process Engineering Acumen
Driving efficiency in manufacturing and product development.
✦ Optimized manufacturing processes for pharmaceutical products.
✦ Applied root cause analysis for OOS and CAPA implementation.
✦ Contributed to project planning and execution for product launches.
Strategic Project Management
Orchestrating complex projects from planning to completion.
✦ Led cross-functional teams in project planning and execution.
✦ Managed timelines, resources, and budgets for key initiatives.
✦ Facilitated communication between departments and stakeholders.
I'm excited about
✦ Connecting with professionals who are shaping the future of pharmaceutical innovation.
✦ Discovering new strategies in regulatory affairs and product development.
✦ Exploring opportunities for collaboration on challenging industry projects.
I can help with
✦ Providing insights on navigating complex regulatory submissions and compliance hurdles.
✦ Sharing best practices for process optimization in pharmaceutical manufacturing.
✦ Offering guidance on project planning and execution for R&D initiatives.
I would love your help on
✦ Learning about emerging trends in drug delivery technologies.
✦ Connecting with experts in intellectual property law for pharmaceuticals.
✦ Finding mentors with experience in international regulatory strategy.
