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Amneal India

Senior Officer, QA Environment Monitoring

Amneal India Sanand, Gujarat, India

Pharmaceutical Manufacturing · 5,001-10,000 employees

8 h ago Closes today
qa Mid (2-5 yrs) Full-time India
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About the role

The Senior Officer is responsible for performing environmental monitoring, line clearance, and in-process quality control activities within a sterile manufacturing environment. They also ensure cGMP compliance, review batch documentation, and manage the calibration and resource requirements for microbiology testing.

What they look for

Environmental Monitoring In-Process Quality Controls Sampling Aseptic Process Simulation Media Fill Line Clearance Batch Record Review Good Documentation Practices Regulatory Compliance Microbiology Sterile Manufacturing Calibration Clean Room Monitoring Non-viable Particle Monitoring Personnel Monitoring Quality Assurance

Requirements

Candidates must hold a B.Sc. or M.Sc. in Microbiology and possess 1 to 6 years of experience in environmental monitoring for a sterile manufacturing plant. Strong knowledge of aseptic processes, regulatory standards, and documentation practices is required.

Full 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 activities
  • Responsible 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) - Expert
  • In-Process Quality Controls (IPQC) & Sampling - Practitioner
  • Aseptic Process Simulation (Media Fill) Monitoring - Expert
  • Line Clearance & Batch Record Review - Practitioner
  • Good Documentation Practices (GDP) - Practitioner
  • Regulatory & 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.

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