Kruthika I n
@kruthikain
I create audit-ready technical and regulatory documentation from complex manufacturing and quality data.
IndiaWhat I'm looking for
At Syngene International, I authored and maintained SOPs, batch manufacturing records, and change controls supporting bioreactor and fermentation operations.
I coordinated process, quality, and engineering reviews for Unit 3 start-up documentation, used Power BI to present critical process data, and prepared records for regulatory filings, inspections, PPQ, and CPV activities. My work maintained 100% compliance across facility inspections.
I'm now applying my biotechnology, clinical research, and controlled-documentation background to medical writing and regulatory documentation, including protocols, clinical study reports, briefing documents, and regulatory responses.
Experience
Work history, roles, and key accomplishments
Life Coach
Freelance / Self-Employed
Jul 2024 - Present (2 years 2 months)
Provided one-on-one coaching to clients on goal-setting, career transitions, and personal development plans, using structured written and verbal frameworks. Applied clear, audience-focused communication and active-listening techniques to translate client goals into actionable, well-organized plans.
Supported upstream MSAT operations and authored/maintained controlled documentation (SOPs, BMRs, change controls) within an electronic quality management system. Coordinated cross-functional review cycles, ensured data accuracy and consistency, and prepared audit-ready documentation to cGMP standards.
Agriculture Research Intern
ICAR – Taralabalu Krushi Kendra
Documented and standardized nutrient-formulation studies to improve fertilizer efficiency, supporting development of market-ready products through field testing. Conducted and recorded QC testing to support agro-industrial process efficiency improvements.
Education
Degrees, certifications, and relevant coursework
M S Ramaiah Institute of Technology
M.Tech, Biotechnology
2019 - 2022
Pursued M.Tech in Biotechnology, gaining advanced knowledge in biotechnological research and applications.
ACRI
PG Diploma, Clinical Research
2016 - 2018
Completed a PG Diploma in Clinical Research, building a strong foundation in clinical research methodologies.
Bapuji Institute of Engineering & Technology
B.E., Biotechnology Engineering
2013 - 2017
Earned a B.E. in Biotechnology Engineering, with a focus on bioprocess and biochemical engineering principles.
McKinsey & Company
McKinsey Leadership Program, Leadership
Completed the McKinsey Leadership Program, developing leadership and problem-solving skills.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Salary expectations
Skills
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