Senior Officer-QA

Job Description

To monitor and review of CPV data before batch release Statistical evaluation of process data by using MINITAB Software Hand on experience in statistical tools like Control chart, Process capability, variance analysis etc. and it s interpretation Having Good drafting skill in technical writing. Review of Master documents Preparation of Annual Product Review / Product Quality Review as per Calendar Schedule To initiate and review of change controls, Risk Assessment and deviations Co-ordinate with internal & external stakeholders to meet the business requirement Preparation of Continued process verification report Identify continuous improvement opportunities to increase compliance, process clarity and operational efficiency Draft response and comply internal/ external audit observations for continued process verification and APQR. Preparation and Review the Standard Operating Procedures implementation of relevant quality policies, standards and procedures for continued process verification and APQR. Track the CAPA as per recommended from CPV & APQR