Senior Executive-QA

Piramal Pharma Ltd; Thane; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Executive-QA to support GMP documentation, PPQ, SOP management and QMS activities. The role covers change controls, deviations, CAPAs, regulatory compliance, and customer complaints handling in a fast-paced quality environment.

The candidate will review BMR, ECR, SOPs and analytical data, participate in Cleaning Validation, and assist in the annual product review and CAPA closure, reporting to the HOD within the QA function.

Qualifications

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

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

Cleaning Validation

QMS activities

Change Controls

Tools

Ensur Software

Job description

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.

Requirements