Perform routine IPQA checks during primary and secondary packaging operations.
- Monitor packaging activities to ensure compliance with approved Batch Packaging Records (BPR) and SOPs.
- Verify product identification, batch details, labeling, coding, and printing activities.
- Ensure proper handling of packaging materials and finished goods.
Line Clearance Activities
- Perform line clearance before batch initiation, product changeover, and batch completion.
- Verify removal of previous product, packaging materials, labels, and documents.
- Ensure area readiness before granting line clearance approval.
- Document line clearance activities as per approved procedures.
Documentation Review
- Review Batch Packaging Records (BPR), logbooks, and packaging documents.
- Ensure completeness, accuracy, and compliance of documentation.
- Identify and report documentation discrepancies.
- Support document reconciliation activities.
Process Monitoring
- Ensure adherence to packaging specifications and quality standards.
Compliance & GMP
- Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
- Monitor personnel adherence to gowning, hygiene, and GMP practices.
- Report and investigate GMP violations and procedural deviations.
- Participate in quality improvement initiatives.
Deviation, Change Control & CAPA
- Report deviations observed during packaging operations.
- Support deviation investigations, root cause analysis, and CAPA implementation.
- Participate in change control assessments related to packaging processes.
Audit Support
- Support internal, customer, and regulatory audits.
- Provide required documents and records during inspections.
- Assist in closure of audit observations related to packaging operations.
Training & Awareness
- Provide GMP and quality compliance guidance to production personnel.
- Participate in quality training programs.
- Promote quality culture across packaging operations.
Interested candidates can send resumes to akash.gogoi@sunpharma.com
Job Location: Palashbari, Guwahati, Assam