Executive - Quality Assurance

Piramal Pharma Ltd; Thane; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Piramal Pharma Solutions in India is seeking an Executive - Quality Assurance to oversee GMP documentation review, process and cleaning validation, and QMS management. The role includes regulatory compliance activities, SOP oversight, and CAPA coordination.

Responsibilities include reviewing BMR/ECR/analytical data, preparing documentation (MMF), and supporting EHS initiatives. The incumbent will report to the HOD and contribute to continuous quality improvements.

Qualifications

• GMP documentation review experience.
• Familiar with process and cleaning validation.
• Experience with QMS activities (CAPA, Change Control, Deviation).
• Regulatory compliance activities and SOP management.

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; monitor validation.
• Preparation of Annual Product Review.
• Preparation and review of SOPs for cross-functional departments.
• Handle Cleaning Validation.
• Handle Dispatch and line clearance activities.
• Initiation of QMS activities like Change Control, Event and CAPA.
• Support EHS activities and report near misses as per EHS requirements.
• Perform any other work assigned by HOD.

Skills

GMP documentation review

Process validation

QMS management

Regulatory compliance

Analytical data review

SOP management

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

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