Head - Quality

Lupin Limited
Applicants0
Posted16 days ago

Job Highlights

Experience4 - 4 Yrs
SalaryUndisclosed
LocationGuwahati
Work ModelOnsite
RoleHead - Quality
Openings3
EmploymentFreelance
EducationM.Pharma

Required Skills

Quality Management Systems (QMS)Good Manufacturing Practices (GMP)Regulatory AffairsQuality Control (QC)Quality Assurance (QA)AuditingValidationCAPA ManagementRisk ManagementTeam LeadershipCommunication SkillsProblem-SolvingPharmaceutical Industry KnowledgeData AnalysisStrategic Planning

Job Description

Role Summary:
We are seeking an experienced and strategic Head - Quality to lead our quality assurance and quality control functions at our Guwahati facility. This pivotal role will ensure adherence to all regulatory standards and drive continuous improvement in quality management systems. The ideal candidate will possess a Master of Arts (M.A.) degree and have 5 to 5 years of progressive experience in quality leadership within the pharmaceutical sector.

Key Responsibilities:
- Develop, implement, and maintain the company's Quality Management System (QMS) in compliance with national and international regulatory requirements (e.g., WHO-GMP, USFDA, EMA).
- Oversee all quality control and quality assurance activities, including batch release, validation, stability studies, and investigations.
- Lead and mentor a team of quality professionals, fostering a culture of quality excellence and compliance.
- Conduct internal audits and manage external regulatory inspections, ensuring successful outcomes.
- Drive continuous improvement initiatives to enhance product quality, process efficiency, and operational excellence.
- Manage deviations, CAPAs, change controls, and risk assessments effectively.
- Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) to ensure quality is integrated throughout the product lifecycle.
- Monitor quality metrics and key performance indicators (KPIs), reporting to senior management.
- Ensure all quality-related documentation is accurate, complete, and compliant.

About Lupin Limited

Lupin Limited is a multinational pharmaceutical company founded in 1968 by Desh Bandhu Gupta. Headquartered in Mumbai, India, Lupin is a significant player in the global pharmaceutical industry, with a strong focus on research and development. The company specializes in a wide range of therapeutic areas, including cardiovascular, anti-infectives, and central nervous system disorders. Lupin has a robust manufacturing and marketing presence across various countries, including India, the United States, Europe, and Japan, and is committed to providing affordable and high-quality medicines.

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