Senior Executive, IPQA EM
Amneal Pharmaceuticals · Ahmedabad
- Experience2–4 yrs
- SalaryNot disclosed
- Work modeunknown
- Levelmid
- Posted17 Sept 2026
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is hiring in Ahmedabad in pharma biotech. This role looks for around 2+ years of experience.
The role
A senior IPQA (In-Process Quality Assurance) executive role at Amneal Pharmaceuticals, ensuring compliance with cGMP and regulatory requirements on the manufacturing and packaging shop floor for injectable pharmaceutical products. You perform real-time monitoring, documentation review, sampling (reserve and stability samples), line clearance and batch record review, and manage deviations, investigations, and CAPA. Required skills include In-Process Quality Control (IPQC), aseptic process monitoring and compliance, deviation & change control management, equipment & facility knowledge, investigation and root cause analysis, and analytical quality assurance, using IPQA instrument calibration and reviewing equipment logbooks, dispensing logs, housekeeping records, environmental monitoring records, and calibration records. The posting is located in Ahmedabad, Gujarat, India (work mode not specified).
Full job description
Description
JOB 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 good written and verbal communication skills in English language.
Qualifications
Education :
Master Degree (MS/MA) M. Sc - Microbiology
Experience
2 years or more in 2 - 4 Years
Skills
In-Process Quality Control (IPQC) - MasteryCompliance and Regulatory Knowledge - AdvancedAseptic Process Monitoring & Compliance - AdvancedLine Clearance & Batch Record Review - MasteryDeviation, Investigation & CAPA Management - AdvancedIn-Process Checks & Monitoring - AdvancedDeviation & Change Control Management - AdvancedEquipment & Facility knowledge - AdvancedInvestigation Skills for Root Cause Analysis - AdvancedAnalytical Quality Assurance - Advanced