Sivakumar Gopalakrishnan
Quality Assurance Officer @Bristol Laboratories Ltd
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WORK HISTORY
Quality Assurance Officer @Bristol Laboratories Ltd
Lead market complaint investigations and prepare trend analyses, supporting faster resolution and risk mitigation. Review Master & Production Batch Records (MBR/PBR), ensuring strict adherence to cGMP standards. Participate in MHRA and internal audits, contributing to inspection readiness and positive outcomes. Drive CAPA and deviation closure within defined timelines, improving Market compliance efficiency. Ensure compliance in controlled drug handling (receipt, storage, dispensing, reconciliation). Conduct IPQA activities (line clearance, gemba walks, visual inspections) to maintain product quality integrity. Prepare, revise, and implement SOPs in line with regulatory updates and industry best practices.
EDUCATION
Karpagam Academy of Higher Education, Coimbatore
Bachelor of Pharmacy - BPharm
University of East London
Master of Science - MS
ABOUT SIVAKUMAR GOPALAKRISHNAN
As a Pharmaceutical Quality Assurance professional, I bring 4+ years of combined…
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