Job Description

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. Responsible 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. Review of and release of Batch. Responsible to review the in-process and finished product COA before batch release. To perform aseptic behaviour/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.

Additional Responsibilities:

Real-time Monitoring and Compliance Reporting. Participation in Investigations. Provide on-the-job training to shop floor personnel on GMP practices, quality standards, and documentation practices. Maintain IPQA-related documents and records in a state of audit readiness. To have good written and verbal communication skills in English language.

Skills:

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

Education: B.Pharm / M.Sc / M.Pharm

Experience: 2 - 4 Years