Executive - Quality Assurance

Piramal Pharma; Navi Mumbai; On-site; INR 550,000 - 850,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Executive - Quality Assurance to support GMP documentation review, process and cleaning validation, and QMS management. You will review BMR, ECR and analytical data, and prepare MMF with regulatory compliance across QA activities.

Your role includes SOP management for cross-functional departments, initiating QMS activities such as Change Control and CAPA, and ensuring EHS tasks are completed on time at our Navi Mumbai site.

Qualifications

• GMP documentation review and regulatory compliance focus.
• QA documentation review including BMR, ECR, MMF and analytical data.
• Cross-functional SOP management and QMS activities.

Responsibilities

• Review BMR, ECR and analytical data.
• Prepare and review MMF.
• Prepare/process validation protocol and reports; monitor validation.
• Handle Cleaning Validation.
• Initiate QMS activities like Change Control and CAPA.
• Ensure EHS related activities and timely dispatch/line clearance.
• Review SOPs across cross-functional departments.

Skills

GMP Documentation

QA Documentation Review

Process Validation

Cleaning Validation

Regulatory Compliance

SOP Management

Analytical Data Review

CAPA Management

Change Control

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 DescriptionQA 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