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Company Description Lezivia Lifesciences is a reputed pharmaceutical company recognized for delivering high-quality products to patients. Most of its products are manufactured at WHO-approved facilities, ensuring adherence to stringent global quality standards. The organization is committed to patient safety, product efficacy, and regulatory compliance. Lezivia Lifesciences offers a professional environment focused on continuous improvement and ethical business practices, making it an attractive workplace for experienced quality professionals.
Role Description This is a full-time, on-site role based in Palghar, Mumbai, for a QA–QMS Manager/Assistant Manager with 10+ years of experience in the pharmaceutical industry. The role involves overseeing Quality Management System (QMS) activities, including documentation control, deviation management, change control, CAPA implementation, and periodic review of SOPs. The professional will lead internal audits, support regulatory and customer audits, and ensure compliance with WHO, GMP, and other relevant regulatory guidelines. Daily responsibilities include coordinating with cross-functional teams to resolve quality issues, training team members on QMS practices, monitoring quality metrics, and driving continuous improvement initiatives across manufacturing and packaging operations.
Qualifications
- Strong experience in Quality Assurance and Quality Management Systems, including documentation control, deviation handling, change control, and CAPA.
- Knowledge of pharmaceutical manufacturing processes, GMP standards, and WHO guidelines, with hands-on experience in audits and regulatory compliance.
- Proficiency in preparing and reviewing SOPs, validation protocols, and quality reports, with attention to detail and accuracy.
- Ability to analyze quality data, identify trends, and implement process improvements across production, packaging, and laboratory functions.
- Excellent communication, leadership, and team coordination skills to manage QA teams and collaborate with cross-functional stakeholders.
- B.Sc., B.Pharm, M.Sc., or M.Pharm degree in a relevant scientific or pharmaceutical discipline.
- Minimum 10 years of QA/QMS experience in the pharmaceutical industry; experience in WHO-approved facilities is an advantage.
- Comfort working on-site in Palghar, with readiness to support extended hours during audits or critical investigations.
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