Executive QA

Job Description

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.