Rakesh Kumar
@rakeshkumar12
I build inspection-ready GMP quality systems for sterile and biologics manufacturing.
United KingdomWhat I'm looking for
At Roslin Cell Therapies, I oversee QMS compliance for aseptic and sterile manufacturing, reviewing GMP deviations, change controls, CAPAs, risk assessments, and batch records supporting product release. Previously at 4basebio UK, I implemented and maintained the PQS, improved organisational compliance from 55% to 85% in seven months, and reduced investigation cycle time by 38% using Six Sigma principles.
Across DAICEL, Biological E., Pfizer Healthcare India, and VIMTA Labs, I've supported biologics, vaccines, microbiology, and GMP operations through regulatory inspections, audit readiness, laboratory compliance, sterility assurance, and data integrity. I've worked with EU GMP, Annex 1, ISO 9001, ISO 17025, USFDA requirements, TrackWise, LIMS, DMS, Dot Compliance, and Simploud.
Experience
Work history, roles, and key accomplishments
Senior Quality Assurance Officer
Roslin Cell Therapies
Mar 2025 - Present (1 year 5 months)
Overseeing daily operations and ensuring comprehensive maintenance and compliance of the Quality Management System (QMS) across Roslin Cell Therapies. Directed review and approval of critical QMS documentation, managed internal audits, and supported regulatory inspections.
Education
Degrees, certifications, and relevant coursework
Osmania University
Master of Science, Microbiology
2011 -
Master of Science in Microbiology from Osmania University.
Tech stack
Software and tools used professionally
Availability
Location
United KingdomAuthorized to work in
Job categories
Skills
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