WALK IN - Interview at Vadodara

0 - 5 years

0 - 1 Lacs

Posted:3 weeks ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Work Location

Organization

Role & responsibilities

Sterile Formulation Activities

  • Prepare buffers, solutions, and bulk formulations as per BMR/BPR.
  • Handle antigen/protein/thawing, compounding, and blending operations.
  • Perform sterile filtration using 0.22/0.45 m filters and validate filter integrity tests.
  • Operate formulation vessels, mixing tanks, transfer pumps, and CIP/SIP systems.
  • Maintain strict aseptic practices and environmental compliance during all activities.
  • Conduct in-process sampling and support stability studies.

Aseptic Filling Operations

  • Operate vial/ampoule/syringe filling machines, isolators, and RABS systems.
  • Perform filling, stoppering, sealing, and inspection activities in Grade A/B zones.
  • Ensure proper line clearance and setup of filling machines.
  • Monitor fill volume accuracy, reject management, and in-process quality checks.

Equipment Handling & Maintenance

  • Execute equipment operation, cleaning, disinfection, and sterilization.
  • Support routine preventive maintenance and calibration activities.
  • Prepare equipment readiness, checklists, logbooks, and validation documents.

Documentation & Compliance

  • Complete BMR/BPR, logbooks, and SOPs in compliance with cGMP and GDP.
  • Participate in deviation investigations, CAPA implementation, and change controls.
  • Support regulatory audits (WHO, USFDA, EMA, CDSCO) and internal quality audits.

Coordination & Safety

  • Coordinate with QA, QC, Engineering, and Warehouse for batch execution.
  • Ensure gowning compliance, equipment safety, and EHS guidelines are followed.
  • Identify process improvements to enhance productivity and aseptic control.

Preferred candidate profile

Injectable, Vaccines, parental, Sterile

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Bharat Biotech International logo
Bharat Biotech International

Biotechnology / Pharmaceuticals

Hyderabad

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