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Senior Officer, QA Environment Monitoring at Amneal Pharmaceuticals — Ahmedabad

Experience1–6 yrs
SalaryNot disclosed
Work modeonsite
Leveljunior
Posted11 Sept 2026

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About Amneal Pharmaceuticals

Amneal Pharmaceuticals is hiring in Ahmedabad in pharma biotech. This role looks for around 1+ years of experience.

Skills

Environmental Monitoring
In-Process Quality Controls (IPQC)
Aseptic Process Simulation (Media Fill) Monitoring
Line Clearance & Batch Record Review
Good Documentation Practices (GDP)
Regulatory & Compliance Knowledge
Process Validation
Cleaning Validation
Hold Time Study
Non-Viable Particle Monitoring
Compressed Air Monitoring
Nitrogen Gas Monitoring
Personnel Monitoring

The role

A quality engineer at a pharmaceutical manufacturing company performs environmental monitoring, aseptic process simulation, and in-process quality controls, and reviews batch records and good documentation practices.

Full job description

Job Description

Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible to perform the environment monitoring activitiesResponsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of executed BMRs and BPRs.Responsible to perform the in-process test at different stages as per batch document/SOP. Responsible to review the environment monitoring, water trends. Responsible to review the different type of planner and calibration certificates. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. Responsible to monitor cGMP compliance at shop floor. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Responsible to participate in perform qualification activities of manufacturing area. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Review of Visual inspector qualification record.

Skills

Environmental Monitoring (EM) - ExpertIn-Process Quality Controls (IPQC) & Sampling - PractitionerAseptic Process Simulation (Media Fill) Monitoring - ExpertLine Clearance & Batch Record Review - PractitionerGood Documentation Practices (GDP) - PractitionerRegulatory & Compliance Knowledge - Practitioner

Qualifications

Education: B.Sc./ M.Sc in Microbiology

Total Experience - 1 - 6 Year inexperience in Environmental Monitoring for sterile manufacturing plant

Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.