QUALITY ASSURANCE TECHNICAL OFFICER/SR. TECHNICAL OFFICER

MENDINE PHARMACEUTICALS PVT LTD

Qualifications: M.PHARM

Experience: in QUALITY ASSURANCE/QUALITY MANAGEMENT SYSTEM in Pharma Industry

Job Objective:

The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands solid documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process.

Job Responsibilities
Quality Risk Management
Batch Manufacturing Record preparation
Process Validation
Packaging Material Specification Preparation
APQR
Cleaning Validation
Batch card preparation
Dossier preparation
Change Control Management
Deviation Management
Endorse documents preparation
Recent drug application
Technology transfer
Drug Regulatory Office communication and handling the Drug regulatory meetings

📌 Quality Assurance Executive Kolkata
🏢 Mendine Pharmaceuticals
📍 Kolkata