Headline

Quality and Document Control Professional, Beckman Coulter Life Sciences

About

Over the past 8+ years, I have built my career at the intersection of quality and manufacturing within GMP- and ISO 13485-regulated medical device and pharmaceutical environments — ensuring that quality is embedded in how a product is made, not treated as a final checkpoint. My work centres on deviations, change control, non-conformances, and CAPAs: taking an issue from initial investigation through root cause analysis to documented, sustainable resolution. I find genuine satisfaction in the investigative side of this work — using structured methods such as 5 Whys and Fishbone analysis to identify true root causes, then collaborating across manufacturing, R&D, and QA to implement corrective action. This is grounded in a solid technical foundation in analytical testing, including flow cytometry, ELISA, spectrophotometry, and bioassay work, which allows me to make quality decisions informed by a real understanding of product and process. I have also served as the primary point of contact during external (BSI) and internal (Beckman Coulter, Danaher) audits. Core areas: QMS (deviations, CAPA, change control, non-conformance) Audit support & regulatory compliance (ISO 13485, ISO 9001, cGxP) Analytical testing & method validation (ELISA, Bioassay, Flow cytometry and stability studies) Computer system validation (21 CFR Part 11) Process improvement (Lean, Kaizen, 5S)

Location

Greater Bengaluru Area

AI stack

claude

gemini

Work experience

Volunteer at SPARC public School, May 2026 - Aug 2026 · 4 mos, Bengaluru, Karnataka, India, • Independently led Mathematics and Science instruction for Class 8 and Class 10 students. • Adapted lessons in real-time to accommodate mixed learning levels, enhancing student engagement. • Managed classroom dynamics effectively, honing people management and conflict-resolution skills. • Implemented structured, feedback-driven teaching adjustments to improve learning outcomes.

Relocation at Career Break, Sep 2025 - Apr 2026 · 8 mos, Berne, Switzerland

Advanced Technician at Beckman Coulter Life Sciences, Sep 2022 - Aug 2025 · 3 yrs, Bengaluru, Karnataka, India, Owned quality-event resolution as QC SPOC — managed change control, deviation and non-conformance investigations, and CAPA actions to closure using 5 Whys and Fishbone analysis. Served as QC's primary contact during external (BSI) and internal (Beckman Coulter, Danaher) audits and performed flow cytometry QC testing and release of in-process and finished IVD/RUO products per ISO 13485. Projects - • Cell line stability study: Led end-to-end design and execution of a shelf-life optimization study — project planning, material procurement, experimental execution, and process documentation — establishing a 20-day shelf life across 5 lyophilized cell lines and delivering a 75% cost reduction against a 50% target. • Training Effectiveness and Compliance: Conducted a comprehensive audit of job codes across all Quality Control documentation to verify relevance and accuracy, identifying and obsoleting redundant codes and documents. Reconciled associate training records against updated job codes, rectifying mismatches to ensure full training compliance and audit-readiness.

Senior Technician at Beckman Coulter Life Sciences, Sep 2020 - Aug 2022 · 2 yrs, Bengaluru, Karnataka, India

Senior Executive at Syngene International Limited, May 2019 - Sep 2020 · 1 yr 5 mos, India, Served as QC SPOC for deviations, change controls, and lab incident reports, authoring SOPs, STPs, and analytical reports in compliance with cGMP standards. Performed sandwich and competitive ELISA immunoassays for potency and stability studies, coordinating with R&D and QA on method transfer. Led computer system validation under 21 CFR Part 11 for lab equipment and software, including IQ/OQ/PQ validation records.

Executive at Syngene International Limited, Apr 2018 - Apr 2019 · 1 yr 1 mo, Bengaluru, Karnataka, India

Technical trainee at Stelis, Apr 2017 - Mar 2018 · 1 yr, India, Maintained GMP-compliant records for cryopreservation of cell lines within a regulated facility. Executed and recorded cell-based assays supporting clinical trial batch release and trained on core GMP equipment including CO2 incubators and biosafety cabinets.

Education

P G Diploma, Cellular and Molecular diagnostics, School of Life Sciences, Manipal