Lupin Hiring Executive – Quality Assurance

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Lupin Hiring Executive – Quality Assurance | M.Pharm & Biotechnology Jobs in Pune

Lupin Limited is inviting applications for the position of Executive – Quality Assurance at its Pune Biotech facility in Maharashtra. This opportunity is ideal for experienced pharmaceutical professionals looking to build their careers in quality assurance, GMP compliance, validation, quality systems, batch release, and regulatory compliance within a globally recognized pharmaceutical organization.

Candidates with a Master’s degree in Biotechnology, Pharmacy, or Pharmaceutical Technology and 3 to 5 years of relevant experience can apply for this role. The position offers exposure to drug substance manufacturing, warehouse quality oversight, process validation, risk assessment, quality investigations, and Annual Product Quality Review (APQR) activities.

Professionals seeking pharmaceutical quality assurance jobs, GMP compliance careers, validation roles, quality systems opportunities, and regulatory affairs support positions will find this opportunity particularly valuable.

Primary Keyword: Quality Assurance Jobs

Company Overview

Lupin Limited is one of India’s leading multinational pharmaceutical companies with a strong presence across branded formulations, biotechnology, active pharmaceutical ingredients (APIs), and specialty pharmaceutical products. The company operates in numerous international markets and is known for maintaining high standards of quality, innovation, and regulatory compliance.

With manufacturing facilities approved by global regulatory agencies, Lupin continues to invest in pharmaceutical research, biotechnology, manufacturing excellence, and quality management systems. The organization focuses on delivering safe, effective, and affordable healthcare products while maintaining compliance with international regulatory standards.

Working at Lupin provides professionals with opportunities to gain experience in regulated pharmaceutical environments, quality systems management, validation programs, regulatory inspections, and continuous improvement initiatives.

Job Role & Responsibilities

Executive – Quality Assurance

Department: Quality Assurance

Experience Required: 3–5 Years

The selected candidate will be responsible for ensuring compliance with GMP guidelines, quality systems, validation requirements, and regulatory standards across manufacturing and warehouse operations.

Manufacturing & Warehouse Compliance

Key Responsibilities

  • Conduct routine visits to drug substance manufacturing facilities.
  • Monitor warehouse operations to ensure GMP compliance.
  • Verify adherence to approved procedures and regulatory requirements.
  • Ensure manufacturing and storage activities comply with quality standards.
  • Support inspection readiness and compliance monitoring activities.

Quality Investigations & CAPA Management

Key Responsibilities

  • Participate in manufacturing investigations.
  • Support root cause analysis activities.
  • Assist in CAPA (Corrective and Preventive Action) finalization.
  • Review investigation reports and closure documentation.
  • Monitor implementation of quality improvement initiatives.

Risk Assessment & Quality Risk Management

Key Responsibilities

  • Prepare risk assessment documents.
  • Review risk mitigation plans.
  • Support implementation of quality risk management strategies.
  • Evaluate process risks and recommend corrective actions.
  • Participate in quality review meetings.

Validation & Qualification Activities

Key Responsibilities

  • Ensure process validation activities are performed according to approved protocols.
  • Verify cleaning validation execution and compliance.
  • Review validation documentation and reports.
  • Monitor qualification activities for manufacturing systems.
  • Support validation lifecycle management.

Documentation Review & Batch Release

Key Responsibilities

  • Review Master Formula Records (MFRs).
  • Review Batch Processing Records (BPRs).
  • Verify execution of manufacturing documentation.
  • Review executed batch records for product release.
  • Ensure compliance with documentation practices and data integrity requirements.

Warehouse Quality Oversight

Key Responsibilities

  • Review Batch Dispatch Records.
  • Verify warehouse dispatch activities.
  • Ensure storage and distribution processes comply with approved procedures.
  • Support quality oversight of warehouse operations.

APQR & Quality Systems

Key Responsibilities

  • Coordinate Annual Product Quality Review (APQR) activities.
  • Compile APQR data from multiple departments.
  • Prepare and review APQR reports.
  • Support quality trend analysis and process monitoring.
  • Participate in quality review meetings and management discussions.

SOP Management

Key Responsibilities

  • Prepare and review Quality System SOPs.
  • Review departmental SOPs for GMP compliance.
  • Ensure document revisions align with regulatory requirements.
  • Support document control activities.
  • Maintain quality system documentation.

Eligibility / Qualifications

Educational Qualification

Candidates should possess any one of the following qualifications:

  • Master’s in Biotechnology
  • M.Pharm
  • Post Graduation in Pharmacy
  • Post Graduation in Pharmaceutical Technology

Relevant Education Background

M.Pharm, Master of Pharmacy, Pharmaceutical Technology, Biotechnology, M.Sc Biotechnology, Industrial Pharmacy, Pharmaceutics, Pharmaceutical Quality Assurance, Pharmaceutical Analysis, Regulatory Affairs.

Experience Requirement

  • Minimum Experience: 3 Years
  • Maximum Experience: 5 Years

Preferred Skills

Candidates with experience in the following areas will be preferred:

  • Quality Assurance
  • GMP Compliance
  • Quality Systems Management
  • Process Validation
  • Cleaning Validation
  • Risk Assessment
  • APQR Preparation
  • Batch Release Activities
  • CAPA Management
  • Manufacturing Investigations
  • Regulatory Compliance
  • Data Integrity
  • SOP Management

Location & Salary

Location: Pune, Maharashtra

Approximate Salary: ₹6 LPA – ₹10 LPA

Why Join Lupin?

Quality Assurance professionals continue to play a critical role in ensuring regulatory compliance, product quality, patient safety, and manufacturing excellence within the pharmaceutical industry.

Key Benefits

  • Opportunity to Work with a Leading Global Pharmaceutical Company
  • Exposure to Regulatory-Compliant Manufacturing Facilities
  • Involvement in Validation and Quality Systems Projects
  • Career Growth in Quality Assurance Functions
  • Experience with APQR and Risk Management Programs
  • Participation in Regulatory Audit Readiness Activities
  • Professional Development Opportunities

This position offers excellent exposure to pharmaceutical quality management systems, manufacturing operations, validation activities, and regulatory compliance frameworks.

Application Process

Eligible candidates can apply online through the official Lupin Careers Portal.

Position Details

Position: Executive – Quality Assurance

Company: Lupin Limited

Location: Pune Biotech, Maharashtra

Experience: 3–5 Years

Application Link

Apply Online: https://careers.lupin.com/job/Pune-Biotech-Executive-Quality-Assurance-MH/1397955500/

Candidates are encouraged to review the eligibility criteria carefully before submitting their applications.

Frequently Asked Questions (FAQs)

1. What qualification is required for the Lupin QA Executive role?

Candidates should have a Master’s in Biotechnology, M.Pharm, Pharmacy, or Pharmaceutical Technology.

2. How much experience is required?

Applicants should possess 3 to 5 years of relevant pharmaceutical quality assurance experience.

3. What quality functions will the selected candidate handle?

The role includes GMP compliance, validation, CAPA management, batch release review, APQR preparation, and SOP management.

4. Is experience in process validation required?

Yes. Experience in process validation and cleaning validation activities is highly relevant for this position.

5. What is the job location?

The role is based at Lupin’s Pune Biotech facility in Maharashtra.

6. What salary can candidates expect?

Based on industry standards, the estimated salary range is approximately ₹6 LPA to ₹10 LPA depending on experience and expertise.

Summary

Category Details
Company Lupin Limited
Department Vacancies Executive – Quality Assurance
Qualification Master’s in Biotechnology, M.Pharm, Pharmacy, Pharmaceutical Technology
Experience 3–5 Years
Location Pune, Maharashtra

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To apply for this job please visit careers.lupin.com.



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