Quality Assurance Head

Michael Page; Ahmedabad District; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Michael Page is seeking a senior QA leader for a leading Indian pharmaceutical manufacturer based in Ahmedabad. The role centers on driving quality excellence, ensuring CGMP/cGLP compliance and managing audits and CAPA programs.

You will oversee batch release decisions, investigations, and data integrity initiatives, while ensuring validation and qualification of facilities and equipment. A strong background in QA and regulatory readiness is essential.

Qualifications

• Strong background in quality assurance within the pharmaceutical industry.
• Good knowledge of regulatory requirements and compliance standards.
• Expertise in cGMP, cGLP, Quality Management Systems, regulatory compliance and inspection preparedness.
• Proven track record in investigations, CAPA management, batch disposition and data integrity.
• Confidence in managing audits and quality reviews.

Responsibilities

• Lead the implementation and continuous improvement of QA systems to ensure CGMP, cGLP and global regulatory compliance.
• Oversee batch release, rejection, and disposition decisions ensuring products meet specs and quality standards.
• Drive investigations and approvals related to OOS, OOT, deviations, market complaints, change controls and CAPA effectiveness.
• Ensure facility, equipment, utilities, software systems, and processes remain qualified and compliant with validation requirements.
• Lead data integrity, quality risk management and contamination control initiatives to safeguard product quality and patient safety.
• Manage regulatory inspections, customer audits, internal audits and self-inspection activities while maintaining audit readiness.
• Monitor quality metrics, compliance trends and site performance indicators, driving corrective actions and continuous improvement.

Skills

Quality Assurance

Regulatory Compliance

cGMP/cGLP

Quality Management Systems

Audits

CAPA Management

Job description

• Lead quality excellence at a leading pharma manufacturer
• Drive regulatory compliance and product quality impact

About Our Client

Our client is one of India's leading pharmaceutical organizations with a strong global footprint across regulated and emerging markets based in Ahmedabad

Job Description

• Lead the implementation and continuous improvement of Quality Assurance systems to ensure compliance with cGMP, cGLP, and global regulatory requirements
• Oversee batch release, rejection, and disposition decisions while ensuring products meet approved specifications and quality standards
• Drive investigations and approvals related to OOS, OOT, deviations, market complaints, change controls, and CAPA effectiveness
• Ensure facility, equipment, utilities, software systems, and manufacturing processes remain qualified and compliant with validation requirements
• Lead data integrity, quality risk management, and contamination control initiatives to safeguard product quality and patient safety.
• Manage regulatory inspections, customer audits, internal audits, and self-inspection activities while maintaining a state of audit readiness
• Monitor quality metrics, compliance trends, and site performance indicators, driving corrective actions and continuous improvement initiatives

The Successful Applicant

We're looking for someone who has:

• A strong background in quality assurance within the pharmaceutical industry.
• Good knowledge of regulatory requirements and compliance standards.
• Strong expertise in cGMP, cGLP, Quality Management Systems, regulatory compliance, and inspection preparedness
• Proven track record in handling investigations, CAPA management, batch disposition, quality risk management, and data integrity program
• Confidence in managing audits and quality reviews.

What's on Offer

• A permanent role in Ahmedabad.
• Opportunity to lead the quality assurance function in the pharmaceutical industry.
• Work in a key position ensuring compliance and product excellence.