Indira W.

I am a multi-talented chemist / manager with a Diploma in Project Management, a Masters‘ degree in Quality Systems / lab management & Analysis and a degree in Biotechnology. I have twenty years’ experience in R&D, Validation, stability, QC and analysis and management in Pharmaceutical industry. Extensive training and skills acquired in the Industry has allowed me to become an expert in laboratory manager, applying quality control and assurance to instrumentation such as HPLC, UPLC, LC/MS/MS, Quality Assurance and Reporting of project data and Annual product reviews, risk assesments and CAPA to improve systems My work history with recent employment is based on QC / QA in Laboratory Management and Internal and External audits. My responsibilities extended to providing QC managing, QA support; product release, producing gap analysis of the analytical and R&D laboratories, recommendation and implementation of a validation program (projects), writing up of Quality Manual, Validation Master Plans and protocols, SOPs and other technical reports, conducting regular meetings, reporting of KPIs, maintenance training records, preparation of R&R and Master Documents by managing and working with stake holders and audits.