Manager / Senior Manager - QA

GLOBAL CALCIUM; Krishnagiri District; On-site; INR 1,200,000 - 1,500,000; Full time

Job summary

GLOBAL CALCIUM in Krishnagiri District is seeking a QA Manager to lead the Quality Assurance department in the API Pharmaceutical Industry. The candidate will ensure compliance with regulatory standards and manage QA team activities, driving continuous improvement initiatives in quality systems.

Ideal candidates should have a Bachelor's degree in a relevant field with 10+ years experience in Pharmaceutical Quality Assurance, along with strong leadership and analytical skills. The position is on-site, focusing on maintaining high-quality healthcare solutions.

Qualifications

• 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.

Responsibilities

• Lead and manage the Quality Assurance department and QA team activities.
• Ensure compliance with cGMP and regulatory standards including USFDA, EDQM, and WHO.
• Conduct root cause analysis and ensure timely closure of CAPA activities.
• Lead internal audits, customer audits, and regulatory inspections.
• Collaborate with Production, QC, Engineering, and Regulatory Affairs teams.

Skills

Strong exposure to API manufacturing QA systems

Experience handling regulatory audits and inspections

Strong leadership and team management capabilities

Good knowledge of cGMP and documentation practices

Expertise in deviation handling, CAPA, and change control

Strong analytical, communication, and problem-solving skills

Education

Bachelor’s degree in Pharmacy, Chemistry or related life sciences

Master’s degree (M.Sc / M.Pharm) preferred

Job description

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