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: In office
? Reporting To: Head – Quality / Site Head
Key Responsibilities:
Leadership & Strategy
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Lead and manage the Quality Assurance department and QA team activities.
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Define departmental quality objectives and ensure effective execution.
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Coach, mentor, and develop team members while promoting a strong quality culture.
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Drive continuous improvement initiatives across quality systems and operations.
Regulatory Compliance
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Ensure compliance with cGMP and regulatory standards including USFDA, EDQM, WHO, and applicable international guidelines.
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Maintain inspection readiness across the facility.
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Implement corrective and preventive actions arising from inspections and audits.
Quality Systems & Documentation
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Oversee preparation, review, approval, and implementation of SOPs, BMRs, validation documents, protocols, specifications, and quality records.
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Ensure effective document management and compliance with data integrity requirements.
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Monitor adherence to ALCOA+ principles and quality management systems.
Investigations & CAPA
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Handle deviations, OOS/OOT investigations, incidents, and market complaints.
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Conduct root cause analysis and ensure timely closure of CAPA activities.
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Manage change control systems and risk assessments effectively.
Audits & Inspections
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Lead internal audits, customer audits, and regulatory inspections.
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Coordinate audit responses, remediation plans, and closure of observations.