Lupin QA Executive Validation & CSV Jobs

Lupin Hiring Executive – Quality Assurance | CSV, Validation & QMS Roles in Pune Biotech

Lupin is hiring for Executive – Quality Assurance positions in its Production and Quality division at Pune Biotech. This opportunity is designed for professionals with strong experience in equipment qualification, computer system validation (CSV), and quality management systems (QMS) within regulated pharmaceutical environments. The role offers exposure to advanced biologics manufacturing, regulatory compliance, and global quality standards.

Company Overview

Lupin is a globally recognized pharmaceutical company with a strong presence in generics, biosimilars, and complex formulations. With operations in over 100 countries, Lupin is known for its regulatory excellence, innovation-driven manufacturing, and commitment to high-quality healthcare solutions.

The Pune Biotech facility focuses on advanced biologics and sterile manufacturing processes, making it a critical hub for innovation and compliance-driven pharmaceutical production. Working at Lupin provides hands-on exposure to global regulatory frameworks including USFDA, EMA, and WHO standards.

Job Role & Responsibilities

As an Executive – Quality Assurance, you will handle validation, qualification, and QMS activities to ensure compliance with global regulatory requirements.

Equipment Qualification

• Prepare and review Equipment Qualification protocols and final reports
• Monitor and execute IQ, OQ, and PQ activities
• Review vendor and third-party qualification documents for integrated instruments
• Perform periodic validation including steam sterilizer validation, thermal mapping, HVAC qualification, and LAFU/BSC validation
• Ensure compliance with regulatory expectations and validation standards

Computer System Validation (CSV)

• Handle validation of server-based, enterprise, and standalone systems
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP guidelines
• Prepare URS, FS, Risk Assessments, IQ/OQ/PQ protocols, RTM, and validation reports
• Validate PLC, HMI, and SCADA-based systems
• Review user access control, data integrity, backup, and disaster recovery systems

Quality Management System (QMS)

• Manage change control, deviation handling, and CAPA processes
• Conduct deviation investigations and implement corrective actions
• Support continuous improvement of quality systems

Documentation & Compliance

• Prepare technical reports and quality risk assessments
• Generate water trend reports and annual equipment performance reports
• Perform gap assessments against regulatory guidelines
• Ensure audit readiness and compliance with GxP requirements

This role is critical in maintaining product quality, regulatory compliance, and operational excellence in pharmaceutical manufacturing.

Eligibility / Qualifications

Candidates must meet the following criteria:

• Graduation in Pharmacy or Engineering
• Post-graduation in Pharmacy or Biotechnology preferred
• Relevant experience in qualification, validation, and QMS activities

Relevant courses include: B.Pharmacy, M.Pharmacy, B.Tech Biotechnology, B.Tech Chemical Engineering, MSc Biotechnology, Pharmaceutical Quality Assurance

Key skills required:

• Strong knowledge of GxP, validation lifecycle, and regulatory compliance
• Hands-on experience in CSV, equipment qualification, and QMS
• Understanding of global regulatory guidelines (USFDA, EU, WHO)
• Analytical thinking and problem-solving skills
• Strong documentation and audit readiness skills

Location & Salary

• Location: Pune Biotech, Maharashtra
• Salary: As per industry standards for QA and validation roles

Application Process

Interested candidates can apply through the official Lupin careers portal:

Apply Here: https://careers.lupin.com/job/Pune-Biotech-Executive-Quality-Assurance-MH/1384430500/

Ensure your resume highlights your experience in validation, CSV, QMS, and regulatory compliance to improve your chances of selection.

Frequently Asked Questions (FAQs)

1. What is the main focus of this role?
The role focuses on equipment qualification, computer system validation, and quality management systems.

2. What qualifications are required?
Candidates must have a degree in Pharmacy or Engineering.

3. Is experience mandatory?
Yes, relevant experience in QA, validation, or CSV is required.

4. What regulatory knowledge is expected?
Understanding of 21 CFR Part 11, EU Annex 11, and GAMP guidelines is important.

5. Where is the job located?
The role is based in Pune Biotech, Maharashtra.

Summary Table

Company	Lupin
Vacancies	Executive – Quality Assurance
Required Education	B.Pharmacy, M.Pharmacy, B.Tech, MSc Biotechnology
Experience	Relevant QA/Validation Experience

Tagged as: pharma jobs in pune