Amneal India Careers has posted an opening for the role of Officer, IPQA in Ahmedabad, Gujarat. The position is suitable for B.Pharm candidates with experience in quality assurance, IPQA, documentation, GMP compliance, and batch record review activities.

Overview

Responsibilities

• Conduct cGMP and compliance review in the GMP area as per cGMP guideline.
• Perform machine and area clearance.
• Carry out sampling of blend, intermediate stages, AQL finished product, ANSI sample, reserve sample, stability sample, and in-process checks during batch manufacturing and packaging execution as per Process Study Protocol (PSP), Process Validation Protocol (PVP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), and miscellaneous protocol-based study.
• Issue bottle label, outsert, and medication guide for commercial batch.
• Review documents and records such as equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, and calibration records.
• Calibrate IPQA instruments.
• Supervise dispensing activity of raw material and packaging material.
• Review executed Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR), and release for next stage.

Qualifications

• B. Pharm is required.
• M. Pharm is preferred.
• 2 years or more experience in the 2 – 5 years range.

Required Skills

• Batch Documentation Record & Review
• Data Integrity & Documentation Security
• Documentation & Record Control
• Good Documentation Practices (GDP)
• IPQA
• Inspection & Particulate Removal
• Line Clearance and Readiness
• Material Handling and Storage
• Quality Assurance
• Regulatory Label Compliance Review

How to Apply

Interested candidates can apply online through the Amneal India Careers job posting.