Executive - Quality Assurance

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

Job summary

Piramal Pharma Solutions in Navi Mumbai is seeking an Executive - Quality Assurance to ensure compliance with cGMP, GDP and QA systems. The role involves reviewing BMR, ECR and analytical data, managing documentation in Ensur software, and supporting annual product reviews and change controls.

You will coordinate with Production, QA, Engineering and R&D teams, handle deviations, validations, and batch release processes, and help ensure regulatory readiness.

Qualifications

• M.Sc (Chemistry) or B. Pharm or M. Pharm required.
• 1–3 years of experience in quality assurance in pharma.
• Strong knowledge of cGMP, GDP and pharmaceutical quality systems.

Responsibilities

• Review of executed BMR, ECR and Analytical Raw Data.
• Review of BMR, ECR and MMF in Ensur Software.
• Prepare Process validation protocol and report; monitor validation activities.
• Dispatch, line clearance and SOP preparation/review.
• Prepare Annual Product Review; handle Cleaning Validation.
• Review Analytical data, Audit Trail and Batch release; initiate deviations and change controls.

Skills

cGMP

GDP

Quality systems

BMR

ECR

MMF

APR/PQR

Analytical data review

Data integrity

Education

M.Sc (Chemistry)

B. Pharm

M. Pharm

Tools

Ensur Software

Job description

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal 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.comJob TitleExecutive - Quality AssuranceJob DescriptionJob 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 - QAQualification : M.Sc (Chemistry) / B. Pharm / M. PharmExperience (No of Years) : 1-3 yearsSkills 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.