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

Qualifications