Executive QA

Role & responsibilities

• Review of BMR, ECR and Analytical Raw Data.
• Review of QC Analytical data.
• Preparation and Review of BMR, ECR, MMF.
• Preparation and review of Process validation protocol and Report.
• Monitoring of process validation.
• Preparation of Annual Product Review.
• Preparation and review of SOPs of Cross Functional Department.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• Initiation of QMS related activities like Change Control, Event and related CAPA.
• To ensure the EHS (Environmental Health and Safety) related activities to be completed on time and to support EHS activity as per requirement.
• To report near miss and incidences as observed as per EHS requirement.

Preferred candidate profile

• Good knowledge of cGMP, GDP, and pharmaceutical quality systems.
• Experience in BMR, ECR, MMF, and analytical data review.
• Understanding of Quality Control analytical documentation and data integrity requirements.
• Familiarity with Annual Product Review (APR/PQR) preparation and documentation.