Senior Executive-QA

Piramal Pharma Ltd; Navi Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) providing end-to-end development and manufacturing across the drug life cycle. We serve global clients with facilities in North America, Europe and Asia.

The Senior Executive-QA role focuses on GMP documentation, PPQ, SOP management, Cleaning Validation, and QMS activities including Change Controls, Deviations, CAPAs, customer complaints, and regulatory compliance.

Qualifications

• GMP documentation practices and PPQ processes are essential.
• SOP management and change controls are core duties.
• CAPA tracking and regulatory compliance understanding is required.
• Handling deviations and customer complaints as part of QA.

Responsibilities

• Review executed BMR, ECR and Analytical Data.
• Review BMR, ECR and SOP in Ensur Software.
• Prepare and monitor Process Performance Qualification protocols.
• Prepare and review Annual Product Review.
• Prepare and review SOPs.
• Handle Cleaning Validation.
• Oversee dispatch and line clearance activities.
• Coordinate QMS related activities like Change Control, Deviations, and CAPAs.
• Participate in handling customer complaints, returns, and product recalls.
• Perform evaluations of various QMS activities.
• Assist in other duties as assigned by HOD.

Skills

GMP Documentation

PPQ

SOP Management

CAPA

Change Controls

Regulatory Compliance

QA Review

Deviations

Job description

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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 andproduct recall.


• Evaluation of various QMS related activities like Change Control, Event (Deviation/ Incident).


• Any other work assigned by HOD.