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 robust 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.

📌 Manager / Senior Manager - QA (Hosur)
🏢 Global Calcium
📍 Hosur