27 Oct
|
Amneal India
|
Ahmedabad
27 Oct
Amneal India
Ahmedabad
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:
• 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. Qualifications
Education:
• Bachelors Degree (BA/BS) B. Pharm
- Required
• Master Degree (MS/MA) M. Pharm
- Preferred
Experience:
• 2
- 4 Years
📌 Officer, IPQA (Ahmedabad)
🏢 Amneal India
📍 Ahmedabad