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

- Robust 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

📌 Senior Executive QA (Navi Mumbai)
🏢 Piramal Pharma
📍 Navi Mumbai