Archana Singh

About Archana Singh

As a Quality Assurance professional at Cipla Limited, I bring extensive experience in end-to-end software validation for GxP-regulated systems, specializing in Category 4 and 5 applications. I ensure strict adherence to global regulatory guidelines including 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 principles. I have a strong command of the Software Development Life Cycle (SDLC), managing V-model,Waterfall and Agile methodologies to deliver compliant and audit-ready systems. My responsibilities span across key Quality Management System (QMS) activities, including the handling of incidents, deviations, and change controls. I focus on robust root cause analysis and the implementation of effective Corrective and Preventive Actions (CAPA) to drive continuous improvement. With a commitment to data integrity, risk-based thinking, ALCOA+, and regulatory compliance, I collaborate cross-functionally to ensure that computerized systems meet both business needs and regulatory expectations.

Experience

1. Senior Executive Quality Assurance

   Cipla

   Aug 2023 — Present · Sikkim, IN

   Actively participated QMS activities including Incident, Deviation, OOS/OOT investigations, Change control with effective root cause analysis and CAPA implementation.• Spearhead end-to-end Computer System Validation (CSV) for GxP-regulated Category 3, 4 & 5 systems as per GAMP 5, 21 CFR Part 11, and EU Annex 11.• Review and approve URS, DQ, IQ, OQ, PQ deliverables, ensuring alignment with SDLC (V- model,Waterfall & Agile).• Approve method validation and verification protocols; review data for analytical systems (HPLC, GC, UV, IR, Malvern, Tiamo).• Proficient in regulated software and platforms including LIMS, CipDox, LMS,SAP, TrackWise,Chromeleon,Lab solutions.• Administer and coordinate LMS training (Tier 1) including e-learning content, program creation, classroom scheduling, and audit trail reviews. •Ensure data integrity and compliance readiness through cross-functional collaboration and continuous process improvement.• Actively support audit preparedness and regulatory inspections by ensuring documentation and systems are always inspection-ready.

Education

• Kalinga University, Raipur

  Masters of science

• Guru Ghasidas University

  Bsc

  2017 — 2020

• Krishna public school nehru nagar bhilai Chhattisgarh

  CBSE 12th

  2016 — 2017

• D.VM public school Anuppur (M.P)

  CBSC 10th

  2014 — 2015