Job Description

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