About the role
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
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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.
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Ensure audit preparedness and compliance sustainability.
Batch Review & Release
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Ensure timely and compliant batch review and release activities.
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Review quality data and support disposition decisions as per quality procedures.
Cross-functional Collaboration
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Collaborate with Production, QC, Engineering, Warehouse, and Regulatory Affairs teams.
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Support technology transfers, scale-up activities, and new product introductions.
Performance & Continuous Improvement
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Monitor quality KPIs and identify improvement opportunities.
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Strengthen quality systems through process improvements and compliance initiatives.
Required Skills
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Strong exposure to API manufacturing QA systems
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Experience handling regulatory audits and inspections
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Strong leadership and team management capabilities
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Good knowledge of cGMP, documentation practices, and validation
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Expertise in deviation handling, CAPA, change control, and investigations
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Strong analytical, communication, and problem-solving skills
Qualifications: Required Qualifications
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Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related life sciences field.
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Master’s degree (M.Sc / M.Pharm) preferred.
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Minimum 10 years of experience in Pharmaceutical Quality Assurance.
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Minimum 5 years of relevant experience in API manufacturing QA.
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Minimum 3 years in a managerial or leadership role.
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Experience handling regulatory audits including USFDA, EDQM, WHO, or equivalent agencies.
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Hands-on exposure to cGMP systems, deviations, CAPA, change control, OOS/OOT investigations, and batch release.
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Experience in validation activities including process, equipment, and cleaning validation.
Preferred Qualifications
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10–15+ years of overall QA experience in regulated pharmaceutical environments.
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Experience with highly potent APIs or global regulatory environments.
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Exposure to technology transfer and commercial manufacturing operations.
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Experience implementing quality management systems and data integrity initiatives.
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Quality certifications such as ASQ Certified Quality Auditor/Engineer will be an added advantage.