Executive, IPQA

Amneal India; Ahmedabad District; On-site; INR 350,000 - 550,000; Full time

Job summary

Amneal India is seeking an IPQA professional to ensure day-to-day GMP compliance on the shop floor. You will support on-floor QA, review batch records, and ensure data integrity during manufacturing, packing, and dispensing activities.

The role requires 1 year or more in IPQA or related QA in pharma, with B. Pharm as a minimum and M. Pharm preferred. On-site work with strong documentation practices and readiness for audits.

Qualifications

• B. Pharm is required; M. Pharm preferred.
• 1 year or more in IPQA or 1-4 years in QA roles at pharma site.
• Strong GMP knowledge and familiarity with 21 CFR Part 210 & 211.
• Accurate documentation, data integrity and on-floor QA support.

Responsibilities

• Perform IPQA activities during manufacturing and packing operations.
• Review and release Batch Manufacturing Records and Batch Packing Records.
• Conduct line clearance, in-process checks, and environmental monitoring.
• Ensure GDP-compliant documentation and participate in GMP inspections.

Skills

IPQA

Line clearance

Environmental monitoring

GDP

Documentation

Audits

Education

B. Pharm

M. Pharm

Tools

Calibration instruments

Environmental monitoring equipment

Job description

Description

The role is responsible for ensuring day-to-day compliance with global GMP (Good Manufacturing Practices) during manufacturing, packing, and dispensing activities at the site. The role provides on-floor quality assurance support, ensuring operations are performed as per approved procedures, validated processes, and regulatory expectations. The role performs line clearance, in-process checks, routine area monitoring, and documentation review, ensuring data integrity, product quality, and patient safety. The position supports cleaning validation, process validation, and aseptic process simulations, and assists in deviation management and inspection readiness, contributing to consistent, compliant, and right-first-time pharmaceutical manufacturing.

Essential Functions

• Perform IPQA (In-Process Quality Assurance) activities during manufacturing and packing operations
• Oversee calibration of IPQA instruments
• Review of and release of Batch
• Review the in-process and finished product COA before batch release
• Keeping records & review of equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch records
• Execute Line Clearance and Readiness for manufacturing, packing, and dispensing areas
• Conduct routine In-Process Checks and coordinate with IPQC (In-Process Quality Control)
• Ensure compliance with 21 CFR Part 210 & 211 (Code of Federal Regulations – Current Good Manufacturing Practice for Drugs)
• Review BMR (Batch Manufacturing Record) and BPR (Batch Packing Record) for accuracy
• Perform Environmental Monitoring and routine monitoring of manufacturing areas
• Ensure assurance of cleaning, sterilization, and aseptic manipulations
• Support Sampling of Cleaning Validation and record compilation
• Assist in Process Validation Reports (PVR – Process Validation Report) activities
• Support Aseptic Process Simulation (Media Fill) monitoring
• Ensure Good Documentation Practices (GDP – Good Documentation Practices) compliance
• Participate in Routine GMP Inspections and quality record reviews

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.

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 1 year or more in 1 - 4 Years