Executive - Quality Assurance

piramalpharma; Turbhe; On-site; INR 500,000 - 700,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Executive - Quality Assurance to join our QA team in India. The role focuses on GMP documentation review, validation activities, QMS management, and regulatory compliance support to ensure product quality and lifecycle governance.

Key responsibilities include BMR/ECR/MCF reviews, SOP maintenance, incident handling, and sustaining EHS programs in a fast-paced CDMO environment. Prior QA exposure in pharma manufacturing is preferred.

Qualifications

• GMP documentation review experience
• Process and cleaning validation experience
• QMS management including Change Control, Deviation/Event, CAPA
• Analytical data review experience
• SOP management and regulatory compliance awareness
• Review of BMR, ECR and Analytical Raw Data

Responsibilities

• Review of BMR, ECR and Analytical Raw Data.
• Review QC Analytical data.
• Prepare and review BMR, ECR, MMF.
• Prepare and review Process validation protocol and report; monitor process validation.
• Prepare Annual Product Review.
• Prepare and review SOPs for Cross Functional Departments.
• Handle Cleaning Validation.
• Handle Dispatch and line clearance activities.
• Initiate QMS related activities such as Change Control, Event and CAPA.
• Ensure EHS activities are completed on time and support EHS requirements.
• Report near-misses and incidences as observed per EHS requirements.

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

Executive - Quality Assurance Job Description

Responsibilities

• 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