QA Head - Pharmaceuticals / Formulations / Sterile Manufacturing - Kheda/Ahmedabad

Position Title: Senior Quality Assurance Head
Department: Quality Assurance
Reports To: Managing Director / CEO
Location: Kheda/Ahmedabad

Role Summary
The Senior Quality Assurance Head will lead the Quality Assurance function, ensuring that all products are manufactured, tested, and released in compliance with cGMP, regulatory standards, and international guidelines. This role drives a strong quality culture, regulatory compliance, and continuous improvement across the organization.

Key Responsibilities

• Lead and manage the Quality Management System (QMS) in alignment with cGMP, WHO, USFDA, EMA, and other global standards.
• Approve and release batches, manufacturing records, and critical quality documents.
• Oversee deviations, CAPA, change controls, complaints, and risk assessments.
• Manage internal audits, customer audits, and regulatory inspections; ensure timely response and closure.
• Approve SOPs, policies, and controlled documents while ensuring data integrity (ALCOA+).
• Guide and mentor QA teams; conduct training programs to strengthen compliance culture.
• Lead qualification and validation activities (equipment, utilities, processes, cleaning, computer systems).
• Drive continuous improvement projects and monitor QA KPIs.

Qualifications and Experience

• M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Sciences or related discipline.
• Minimum 15 years of QA experience in pharmaceuticals, with 5+ years in a leadership role.
• Proven expertise in handling regulatory audits (USFDA, EMA, MHRA, WHO, etc.).
• Experience in sterile/injectable or formulation facilities preferred.

Core Competencies

• Strong knowledge of GMP, GLP, GDP, ICH guidelines.
• Leadership with the ability to build a compliance-driven quality culture.
• Excellent analytical, problem-solving, and decision-making skills.
• Effective communication and cross-functional collaboration.

Key Performance Indicators (KPIs)

• Zero major or critical regulatory observations.
• Timely closure of deviations, CAPAs, and audit findings.
• 100% compliance in batch release and documentation.
• High training effectiveness and employee compliance awareness.

Industry: Pharmaceuticals / Formulations / Sterile Manufacturing
Experience: Minimum 15 years (with at least 5 years in a leadership role)
Compensation: As per industry standards

With Regards,
Himani(HR)
9377165778

Job Types: Full-time, Permanent

Pay: ₹1,000,000.00 - ₹1,200,000.00 per month

Work Location: In person