Senior Executive-QA

Piramal Pharma Ltd; Thane; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Piramal Pharma Solutions in Thane, Maharashtra is seeking a Senior Executive-QA to join our GMP-focused QA team. You will review BMR/ECR, SOPs, and ensure regulatory compliance across the documentation lifecycle.

The role covers PPQ, Change Controls, CAPAs, customer complaints, and QMS activities, with hands-on work in Ensur Software and daily collaboration with the HOD to maintain GMP standards.

Qualifications

• GMP documentation experience and QA domain knowledge.
• Experience in PPQ, SOP management, and QMS processes.
• Handling deviations, CAPAs, change controls and regulatory compliance.
• Review of BMR/ECR and SOP in Ensur Software.

Responsibilities

• Review of executed BMR, ECR and Analytical Data.
• Review of BMR, ECR and SOP in Ensur Software.
• Preparation of Process Performance Qualification protocol & Monitoring of Process Performance Qualification activities.
• Preparation and Review of Annual Product Review.
• Preparation and review of SOPs.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• 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.

Skills

GMP Documentation

PPQ

SOP Management

QMS

Change Control

Deviations

CAPA

Customer Complaints Handling

Regulatory Compliance

BMR/ECR Review

Ensur Software

Tools

Ensur Software

Job description

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit: www.piramalpharmasolutions.com

Job Title

Senior Executive-QA

Job Description

QA professional experienced in GMP documentation, PPQ, SOP management, Cleaning Validation, and QMS activities including Change Controls, Deviations, CAPAs, customer complaints, and regulatory compliance.

• Review of executed BMR, ECR and Analytical Data.
• Review of BMR, ECR and SOP in Ensur Software.
• Preparation of Process Performance Qualification protocol & Monitoring of Process Performance Qualification activities.
• Preparation and Review of Annual Product Review.
• Preparation and review of SOPs.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• 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.