Senior Executive, IPQA

Description

JOB DESCRIPTION

To ensure compliance with cGMP and regulatory requirements by performing in-process quality assurance activities on the manufacturing and packaging shop floor, including real-time monitoring, documentation review, sampling, and area / machine clearances, thereby supporting the production of high-quality injectable pharmaceutical products

Essential Functions

• To ensure cGMP and compliance review in the manufacturing shop floor and packing areas.
• To supervision of dispensing activity of manufacturing shop floor and packing areas.
• To Issuance of Bottle label, Ouster and Medication guide for commercial batch.
• Rsponsible for providing machine and area clearance.
• To conduct Sampling of reserve sample, stability sample and In-process checks during execution of batch packaging as per Batch Packaging Record (BPR) and stability study protocol.
• Online Documents and records review like equipment's logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records etc..
• Calibration of IPQA instruments.

Additional Responsibilities

Qualifications

Education :

Experience

Skills

Skills Required

In-Process Checks Monitoring - Advanced, Line Clearance Batch Record Review - Mastery, In-Process Quality Control IPQC - Mastery, Deviation Change Control Management - Advanced, Analytical Quality Assurance - Advanced, Compliance and Regulatory Knowledge - Advanced, Aseptic Process Monitoring Compliance - Advanced, Equipment Facility knowledge - Advanced, Investigation Skills for Root Cause Analysis - Advanced, Deviation Investigation CAPA Management - Advanced