Quality Head

Cadchem Laboratories Ltd

API Pharmaceutical Plant

Quality Head

Qualification : M.Pharm / MSc / PhD

Experience : 15 - 20 years of experience in API pharmaceutical

Key Responsibilities

Quality Management & Compliance

• Establish, implement, and maintain the Quality Management System (QMS) in compliance with cGMP, ICH, USFDA, EU-GMP, WHO, PMDA, and other regulatory standards.
• Ensure compliance with regulatory requirements throughout the API lifecycle.
• Act as the Authorized/Qualified Person for batch release (as applicable).

Regulatory Affairs & Audits

• Lead and manage regulatory inspections (USFDA, EDQM, WHO, CDSCO, customer audits).
• Prepare and review responses to 483s, Warning Letters, audit observations, and CAPAs.
• Ensure readiness of site documentation and data integrity practices.

Documentation & Data Integrity

• Oversee preparation, review, and approval of:
• SOPs, STPs, protocols, and reports
• Validation documents
• Deviations, OOS, OOT, change controls
• Ensure ALCOA+ data integrity compliance across all quality systems.

Quality Control & Validation Oversight

• Provide strategic oversight to QC, stability studies, and analytical compliance.
• Approve validation and qualification activities:
• Process validation
• Cleaning validation
• Equipment qualification (IQ/OQ/PQ)
• Method validation and transfer

Risk Management & Continuous Improvement

• Drive Quality Risk Management (QRM) activities as per ICH Q9.
• Promote continuous improvement initiatives and quality culture.
• Analyze trends, KPIs, and quality metrics to prevent recurrence of issues.

People & Leadership

• Lead, mentor, and develop QA & QC teams.
• Ensure training, competency development, and performance management.
• Foster a strong quality mindset across manufacturing, engineering, and R&D.

Job Types: Full-time, Permanent

Pay: ₹2,200,000.00 - ₹2,500,000.00 per year

Work Location: In person