Executive, IPQA
Amneal Pharmaceuticals · Ahmedabad
- Experience1–4 yrs
- SalaryNot disclosed
- Work modeonsite
- Leveljunior
- Posted14 Sept 2026
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is hiring in Ahmedabad in pharma biotech. This role looks for around 1+ years of experience.
Skills
- Good Manufacturing Practices
- 21 CFR Part 210 & 211
- Good Documentation Practices
- Line Clearance
- In-Process Checks
- Environmental Monitoring
- Batch Manufacturing Record
- Batch Packing Record
- Cleaning Validation
- Process Validation
- Aseptic Process Simulation
- Data Integrity
The role
An in-process quality assurance executive at a pharmaceutical manufacturing company ensures Good Manufacturing Practices and aseptic processing across production operations, applying cleaning validation and process validation. The role also performs environmental monitoring and batch record review.
Full job description
Description
JOB 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 operationsOversee calibration of IPQA instruments Review of and release of Batch Review the in-process and finished product COA before batch releaseKeeping records & review of equipment’s logbooks, dispensing logs, housekeeping records, environmental monitoring records, calibration record, batch recordsExecute Line Clearance and Readiness for manufacturing, packing, and dispensing areasConduct 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 accuracyPerform Environmental Monitoring and routine monitoring of manufacturing areasEnsure assurance of cleaning, sterilization, and aseptic manipulationsSupport Sampling of Cleaning Validation and record compilationAssist in Process Validation Reports (PVR – Process Validation Report) activitiesSupport Aseptic Process Simulation (Media Fill) monitoringEnsure Good Documentation Practices (GDP – Good Documentation Practices) complianceParticipate 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
QUALIFICATIONS
B. Pharm B. Pharm - RequiredM. Pharm M. Pharm - Preferred
Experience:
1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses: