Executive - Quality Assurance

Piramal Pharma Ltd; Thane; On-site; INR 550,000 - 750,000; Full time

Job summary

Piramal Pharma Solutions in Thane, India, seeks an Executive - Quality Assurance to ensure GMP documentation review, validation activities, and regulatory compliance across the manufacturing lifecycle.

You will review BMR/ECR, QC data, SOPs, and oversee QMS processes, CAPA, change controls, deviations, and EHS-related tasks, coordinating with cross-functional teams to maintain product quality and audit readiness.

Qualifications

• Experience in GMP documentation review and regulatory compliance.
• Hands-on exposure to process and cleaning validation.
• Strong understanding of QMS processes including Change Control, Deviation/Event, and CAPA.

Responsibilities

• Review of BMR, ECR and Analytical Raw Data.
• Review of QC Analytical data.
• Preparation and Review of BMR, ECR, MMF.
• Preparation and review of Process validation protocol and Report. Monitoring of process validation.
• Preparation of Annual Product Review.
• Preparation and review of SOPs of Cross Functional Department.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• Initiation of QMS related activities like Change Control, Event and related CAPA.
• Ensure EHS related activities to be completed on time and support EHS requirements.

Skills

GMP documentation review

Process validation

Cleaning validation

QMS management

Deviation management

CAPA

Analytical data review

SOP management

Regulatory compliance

Job description

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

Executive - Quality Assurance

QA professional experienced in GMP documentation review, process and cleaning validation, QMS management (Change Control, Deviation/Event, CAPA), analytical data review, SOP management, and regulatory compliance activities.

• Review of BMR, ECR and Analytical Raw Data.
• Review of QC Analytical data.
• Preparation and Review of BMR, ECR, MMF.
• Preparation and review of Process validation protocol and Report. Monitoring of process validation.
• Preparation of Annual Product Review.
• Preparation and review of SOPs of Cross Functional Department.
• Handling Cleaning Validation.
• Handling Dispatch and line clearance activity.
• Initiation of QMS related activities like Change Control, Event and related CAPA.
• To ensure the EHS (Environmental Health and Safety) related activities to be completed on time and to support EHS activity as per requirement. To report near miss and incidences as observed as per EHS requirement.
• Any other work assigned by HOD

Requirements