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 valuable 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