Executive - Quality Assurance

Piramal Pharma Ltd; Navi Mumbai; On-site; INR 500,000 - 700,000; Full time

Job summary

Piramal Pharma Solutions is looking for an Executive - Quality Assurance to join our GMP-compliant QA team in Navi Mumbai. You will review GMP documentation, BMR, ECR and analytical data, and support validation activities across processes and cleaning.

The role involves preparing and reviewing MMF, SOPs, CAPA/Change Control, deviations, and regulatory compliance documentation, ensuring timely completion of EHS tasks in coordination with the department.

Qualifications

• 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.

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.
• To ensure the EHS (Environmental Health and Safety) related activities to be completed on time and to support EHS activity as per requirement.

Skills

GMP documentation

Process validation

Cleaning validation

QMS management

CAPA

Change Control

Regulatory compliance

SOP management

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

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