Senior Executive - Quality Assurance

Piramal Pharma Ltd; Kohir mandal; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Executive - Quality Assurance to lead vendor qualification and requalification activities ensuring compliance with cGMP and regulatory requirements. You will coordinate audits, review qualification documents, and manage CAPA responses, while partnering with CQA, SCM, Manufacturing, and R&D teams to keep the supplier base qualified.

The role involves risk-based supplier qualification, ongoing monitoring, and supporting regulatory and customer audits

Qualifications

• Experience in vendor qualification and audits per cGMP and regulatory requirements.
• Knowledge of ICH guidelines and regulatory expectations for supplier quality.

Responsibilities

• Plan, coordinate and execute vendor qualification, requalification and surveillance activities.
• Evaluate vendors for raw materials, starting materials, intermediates, packaging materials and other services as applicable.
• Review vendor qualification documents including GMP certificates and audits; prepare CAPA responses and closure.
• Maintain vendor evaluation reports, CAPA tracking and related quality documentation.
• Coordinate with CQA, SCM, Manufacturing, R&D, Regulatory, and other teams for qualification and monitoring.
• Support regulatory and customer audits by providing vendor documentation.

Skills

Vendor qualification

Quality assurance

Audit coordination

CAPA tracking

Risk assessment

Cross-functional coordination

Regulatory knowledge

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

Senior Executive - Quality Assurance

Job Description

Responsible for planning, coordinating, and executing vendor qualification and requalification activities in compliance with cGMP, regulatory requirements, and applicable company procedures. The role includes assessment of new and existing vendors, review of vendor qualification documents, coordination of vendor audits, evaluation of audit observations and CAPA responses, and preparation/review of vendor assessment reports.

The position will also support vendor performance monitoring, risk-based supplier qualification, periodic surveillance assessments, and coordination with Quality, SCM, Manufacturing, and other cross-functional teams to ensure qualified vendors consistently meet the required quality and compliance standards.

• Plan, coordinate, and execute vendor qualification, requalification, and periodic surveillance activities based on risk and applicable regulatory requirements.
• Evaluate vendors for raw materials, starting materials, intermediates, packaging materials, and other critical services, as applicable.
• Review vendor qualification documents, including questionnaires, quality agreements, GMP certificates, regulatory approvals, audit reports, specifications, and supporting quality documents.
• Preparation of audit plans, review of observations, evaluation of CAPA responses, and follow-up for effective closure.
• Prepare and maintain Vendor evaluation Reports, CAPA tracking, and related quality documentation.
• Conduct risk-based vendor assessments in accordance with applicable SOPs, ICH guidelines, and regulatory expectations.
• Monitor vendor performance through quality trends, deviations, OOS/OOT, complaints, change notifications, and other relevant quality indicators.
• Coordinate with CQA, SCM, Manufacturing, R&D, Regulatory Affairs, and other cross-functional teams for vendor qualification and ongoing monitoring activities.
• Ensure timely completion of vendor qualification activities and maintain the approved vendor list/status in accordance with site procedures.
• Support regulatory and customer audits by providing appropriate vendor qualification and supplier quality documentation.
• Ensure all activities are performed in compliance with cGMP, ICH guidelines, applicable regulatory requirements, and company Quality Management System.