Manager / Senior Manager - QA

QA Manager – API Pharmaceutical Industry About Company Global Calcium Pvt. Ltd is a leading pharmaceutical manufacturing organisation committed to delivering high-quality healthcare solutions with strong regulatory compliance and operational excellence. The company specialises in manufacturing pharmaceutical ingredients and formulations while maintaining global quality standards and customer satisfaction. Location & Reporting Details 📍 Location: Hosur, Tamil Nadu, India 🏢 Work Mode: On-site 🧾 Reporting To: Head – Quality / Site Head Key Responsibilities Leadership & Strategy - Lead and manage the Quality Assurance department and QA team activities. - Define departmental quality objectives and ensure effective execution. - Coach, mentor, and develop team members while promoting a strong quality culture. - Drive continuous improvement initiatives across quality systems and operations. Regulatory Compliance - Ensure compliance with cGMP and regulatory standards including USFDA, EDQM, WHO, and applicable international guidelines. - Maintain inspection readiness across the facility. - Implement corrective and preventive actions arising from inspections and audits. Quality Systems & Documentation - Oversee preparation, review, approval, and implementation of SOPs, BMRs, validation documents, protocols, specifications, and quality records. - Ensure effective document management and compliance with data integrity requirements. - Monitor adherence to ALCOA+ principles and quality management systems. Investigations & CAPA - Handle deviations, OOS/OOT investigations, incidents, and market complaints. - Conduct root cause analysis and ensure timely closure of CAPA activities. - Manage change control systems and risk assessments effectively. Audits & Inspections - Lead internal audits, customer audits, and regulatory inspections. - Coordinate audit responses, remediation plans, and closure of observations. - Ensure audit preparedness and compliance sustainability. Batch Review & Release - Ensure timely and compliant batch review and release activities. - Review quality data and support disposition decisions as per quality procedures. Cross-functional Collaboration - Collaborate with Production, QC, Engineering, Warehouse, and Regulatory Affairs teams. - Support technology transfers, scale-up activities, and new product introductions. Performance & Continuous Improvement - Monitor quality KPIs and identify improvement opportunities. - Strengthen quality systems through process improvements and compliance initiatives. Required Skills - Strong exposure to API manufacturing QA systems - Experience handling regulatory audits and inspections - Strong leadership and team management capabilities - Good knowledge of cGMP, documentation practices, and validation - Expertise in deviation handling, CAPA, change control, and investigations - Strong analytical, communication, and problem-solving skills Qualifications: Required Qualifications - Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related life sciences field. - Master’s degree (M.Sc / M.Pharm) preferred. - Minimum 10 years of experience in Pharmaceutical Quality Assurance. - Minimum 5 years of relevant experience in API manufacturing QA. - Minimum 3 years in a managerial or leadership role. - Experience handling regulatory audits including USFDA, EDQM, WHO, or equivalent agencies. - Hands-on exposure to cGMP systems, deviations, CAPA, change control, OOS/OOT investigations, and batch release. - Experience in validation activities including process, equipment, and cleaning validation. Preferred Qualifications - 10–15+ years of overall QA experience in regulated pharmaceutical environments. - Experience with highly potent APIs or global regulatory environments. - Exposure to technology transfer and commercial manufacturing operations. - Experience implementing quality management systems and data integrity initiatives. - Quality certifications such as ASQ Certified Quality Auditor/Engineer will be an added advantage. Skills: qualification development,validation,qms,data integrity