Quality Assurance Executive

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 strong 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
1) Quality Risk Management
2) Batch Manufacturing Record preparation
3) Process Validation
4) Packaging Material Specification Preparation
5) APQR
6) Cleaning Validation
7) Batch card preparation
8) Dossier preparation
9) Change Control Management
10) Deviation Management
11) Endorse documents preparation
12) New drug application
13) Technology transfer
14) Drug Regulatory Office communication and handling the Drug regulatory meetings