Senior Executive QA

Job Description

Role & responsibilities

Review of executed BMR, ECR and Analytical Data.
Review of BMR, ECR and SOP in Ensur Software.
Preparation of process Performance Qualification (PQ) protocol & monitoring of process Performance Qualification (PQ) activities.
Preparation and review of Annual Product Review.
Preparation and review of SOPs.
Handling cleaning validation.
Handling dispatch and line clearance activities.
Handling of QMS related activities like change control, event (Deviation/ Incident) and related CAPAs.
Participate in handing of Customer Complaints,Return Goods and product recall.
Evaluation of various QMS related activities like Change Control, Event (Deviation/ Incident).
Any other work assigned by HOD

Preferred candidate profile

Strong knowledge of cGMP, GDP, ICH, and regulatory compliance requirements.
Proficiency in Quality Management Systems (QMS) including Deviations, Change Controls, Incidents, CAPA, and Risk Assessments.
Experience in Batch Manufacturing Record (BMR), ECR, SOP, and analytical data review.
Knowledge of Process Validation, Process Performance Qualification (PPQ), and Cleaning Validation activities