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Quality Assurance Assistant Manager

Immacule LifeSciences Pvt Ltd

Nalagarh, Himachal Pradesh

Department: Quality Assurance

Experience: 4 Year

Industry: Pharmaceutical

Education: BPharm

Remarks: Urgent hiring for injectable validation profile

Job Description

Company Introduction

Immacule LifeSciences Pvt Ltd operates a modern pharmaceutical manufacturing facility focused on sterile injectable medicines for regulated markets.

Core Responsibilities

  • Inspect classified cleanroom areas using approved area qualification checklists and calibrated particle monitoring instruments.
  • Verify vial washing machine cycles by reviewing printed cycle charts and physical batch records.
  • Check depyrogenation tunnel temperature profiles using validated data loggers and strip chart records.
  • Review filling line setup through direct observation of equipment settings and completed line clearance documents.
  • Examine autoclave and sterilizer load patterns using load diagrams and biological indicator reports.
  • Assess water system parameters by checking conductivity meters and microbiological test reports.

Skills and Technical Exposure

  • Cleanroom qualification documents and validation master plans.
  • Vial washing machines, filling lines, and depyrogenation tunnels.
  • Autoclaves, sterilizers, and manufacturing vessels.
  • Process validation and cleaning validation protocols.
  • HVAC monitoring tools and environmental monitoring records.
  • GMP documentation formats used in injectable plants.

Experience Context

  • Work is carried out inside sterile injectable manufacturing blocks with controlled environments.
  • Facilities handle multiple filling lines, high volume vial batches, and complex utility systems.
  • Without this role, equipment qualification gaps lead to batch rejection and regulatory observations.

How to Apply

Interested candidates may send their application to eswar.reddy@immacule.in

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