Senior Executive QA

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