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