Executive - Quality Assurance

Piramal Pharma Ltd; Thane; On-site; INR 500,000 - 800,000; Full time

Job summary

Piramal Pharma Solutions is a CDMO providing end-to-end development and manufacturing across the drug life cycle. The Executive - Quality Assurance ensures compliance with quality systems, cGMP, and regulatory standards within the manufacturing environment, reviewing documentation and supporting continuous improvement.

The role involves cross-functional coordination with Production, QA, QC, and Engineering, with emphasis on quality management processes, regulatory readiness, and adherence to EHS

Qualifications

• Experience in quality systems and regulatory standards.
• Familiarity with BMR, ECR, MMF, and data integrity requirements.
• Understanding of analytical documentation and data integrity.
• APR/PQR preparation experience.

Responsibilities

• Review of BMR, ECR and Analytical Raw Data.
• Review of BMR, ECR and MMF in Ensur Software.
• Prepare Process validation protocol and report; monitor validation activities.
• Prepare and review SOPs; prepare Annual Product Review.
• Handle Cleaning Validation; review of Analytics data and Audit Trail.
• Initiate deviations and change controls as needed.
• Issuance, archival and retrieval of R&D/ADL documents.
• Manage quality-related activities in R&D/ADL.

Skills

cGMP knowledge

GDP knowledge

Analytical data review

APR/PQR preparation

Education

M.Sc Chemistry / B.Pharm / M.Pharm

Tools

Ens ur Software

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

Job Description

Job Overview : The Executive - Quality Assurance is responsible for ensuring compliance with quality systems, cGMP requirements, and regulatory standards within the manufacturing environment. The role involves review of production and quality control documentation, validation activities, annual product reviews, quality management system processes, and cross-functional coordination to maintain product quality and compliance. The position supports continuous improvement initiatives, documentation management, regulatory readiness, and adherence to Environmental Health & Safety (EHS) requirements.

Internal Key Stakeholders : Production (Synthesis + Pharma) Team, Quality Assurance Team, Quality Control Team, Engineering Department, etc. (As per the requirement of the allocated task.)

External Key Stakeholders : Auditors, Suppliers, Customers, etc. (As per the requirement of the allocated task.)

Reporting Structure : Deputy Manager - QA

Qualification : M.Sc (Chemistry) / B. Pharm / M. Pharm

Experience (No of Years) : 1-3 years

Skills And Competencies

• Good knowledge of cGMP, GDP, and pharmaceutical quality systems.
• Experience in BMR, ECR, MMF, and analytical data review.
• Understanding of Quality Control analytical documentation and data integrity requirements.
• Familiarity with Annual Product Review (APR/PQR) preparation and documentation.

Key Roles / Responsibilities

• Review of executed BMR, ECR and Analytical Raw Data.
• Review of BMR, ECR and MMF in Ensur Software.
• Preparation of Process validation protocol & report and Monitoring of process validation activities.
• Dispatch and line clearance activity.
• Preparation and review of SOPs.
• Preparation of Annual Product Review.
• Handling Cleaning Validation.
• Review of Analytical data, Audit Trail and Batch release.
• Initiation of Deviations, Change controls whenever required.
• Issuance, archival and retrieval of documents in R&D and ADL.
• Management of quality-related activities in R&D and ADL.
• Review and approval of R&D and ADL document.