Position Overview We are looking for a QMS Specialist for our Sterile Parenteral Plant Injectables The role involves managing all Quality Management System activities ensuring compliance with regulatory requirements and supporting continuous improvement in sterile manufacturing operations Key Responsibilities Manage Change Control CAPA and Deviation handling with timely closure and effectiveness verification Prepare and review Market Complaint investigations and ensure compliance with regulatory timelines Perform Risk Assessments to support decision-making and ensure product quality and patient safety Ensure compliance and timely closure of audit points regulatory customer internal Prepare review and maintain QMS documentation including Quality Management Procedures QMS documents Validation Master Plan VMP Site Master File SMF Review and ensure completeness of Annual Product Quality Review APQR reports Review Batch Manufacturing Records BMR and Batch Packaging Records BPR for accuracy and compliance Support regulatory and customer audits with required QMS documentation and responses Drive continuous improvement initiatives in QMS compliance and operational excellence Collaborate with cross-functional teams Production QC Regulatory Engineering for timely issue resolution Qualifications Experience Education B Pharm M Pharm M Sc Microbiology Biotechnology Chemistry Experience 2-4 years in QA QMS function in a Sterile Parenteral Injectable Plant Good knowledge of cGMP GDocP ICH guidelines and regulatory compliance USFDA EU WHO MHRA Hands-on experience in QMS activities Change Control Deviation CAPA APQR Market Complaints Risk Assessment Strong documentation analytical and communication skills Key Skills Competencies Knowledge of aseptic processing sterile manufacturing and data integrity principles Ability to handle regulatory inspections and audits Proficiency in MS Office and QMS software tools Trackwise Veeva Vault or equivalent Solid attention to detail compliance mindset and problem-solving ability Job Type Level Full-time On-site Patas Pune Designation QMS Specialist QA Job Type Full-time Pay 20 000 00 - 40 000 00 per month Benefits Provident Fund Work Location In person

📌 Qa - Qms Specialist (Maharashtra)
🏢 Steribio Lifesciences Pvt.Ltd
📍 Maharashtra