p
priyadarshanaa

PRIYAAVA

@priyadarshanaa

PharmaDocExpert

Índia
Inglês, Hindi, Marata
Algumas informações são exibidas no idioma inglês.
Sobre mim
I am a Pharmaceutical Technical Writer with 15+ years of experience in Quality Control, GMP documentation, and regulatory compliance. I specialize in creating audit-ready, compliant, and professionally structured pharmaceutical documents that meet global standards including GMP, ICH, and FDA guidelines. Over the years, I have worked on developing, reviewing, and optimizing critical documentation that ensures regulatory approval, operational clarity. 🔬 My Expertise Includes: ✔ SOP (Standard Operating Procedures) Writing ✔ QC Documentation & Analytical Reports ✔ Stability Study Reports... Saiba mais

Habilidades

p
priyadarshanaa
PRIYAAVA
offline • 
Tempo médio de resposta: 1 hora

Conheça meus serviços

Redação Técnica
I will write pharmaceutical sops, gmp documents, and qc reports
A partir deUS$ 15 /projetoMais detalhes

Portfólio

Experiência profissional

Cipla

Quality Control Officer

Cipla • Período integral

Apr 2008 - Jun 2012 • 4 yrs 2 mos

Conducted routine and non-routine quality control testing of pharmaceutical formulations in compliance with GMP guidelines. Performed analytical testing using advanced instruments such as HPLC, GC, FTIR, and Dissolution Apparatus. Prepared and reviewed laboratory documentation, including raw data, analytical reports, and test records ensuring data integrity (ALCOA+) compliance. Supported analytical method validation and verification activities as per ICH guidelines. Assisted in preparation of Standard Operating Procedures (SOPs) and ensured strict adherence within the QC laboratory. Handled out-of-specification (OOS) and out-of-trend (OOT) investigations with proper root cause analysis and documentation. Played a key role in maintaining audit readiness for regulatory inspections including USFDA and WHO audits. Coordinated with cross-functional teams including QA, Production, and Regulatory Affairs for batch release and compliance activities. Ensured compliance with Good Laboratory Practices (GLP) and maintained laboratory safety standards. Contributed to continuous improvement initiatives to enhance efficiency, accuracy, and compliance within QC operations.