Officer/Sr. Officer-QA

Role & responsibilities

• Line clearance in dispensing and production area.
• To perform in-process sampling, testing and document the observations.
• To handle IPQA activity in warehouse and production area.
• Review of BMR, process documents etc.
• APR Preparation.
• To ensure timely validation of production equipments w.r.t. process, cleaning and to collect samples for cleaning validation etc.
• To identify problem areas in manufacturing and report to Head QA.
• To follow GMP and ensuring timely documentation of dispensing, manufacturing and packing activity.
• To oversee the QA activities.
• To maintain QA documents in compliance status.
• Review of SOPs, BMR, qualification / validation documents.
• Maintain the plant equipments in validated status.
• Involve in Risk assessment process.
• Review of change control, deviations, CAPA, incidents, OOS, OOT, market complaints etc.
• To maintain GMP compliance in the plant and ensure all time readiness of facility for inspection.
• Identify problem areas and report to Head-Quality.