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