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3-4 years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Executive
Department: Quality Control
Location: Unit 1
Educational Qualification: M.Sc
Experience Required: 3 - 7 years
Date Posted: 01-03-2024


Job Summary:

The Executive in the Quality Control department is responsible for overseeing critical microbiological processes, including bacterial endotoxin testing, environmental monitoring, media management, and growth promotion testing. The role requires experience in handling microbiological failures, preparing specifications, and maintaining laboratory equipment.


Key Responsibilities:

  • Perform Bacterial Endotoxin Testing.
  • Conduct Viable Environmental Monitoring in classified and aseptic areas.
  • Manage, handle, and perform growth promotion testing for media.
  • Handle and resolve microbiological failures.
  • Maintain in-house and ready-to-use cultures.
  • Prepare and review specifications, STPs, TDS, Validation protocols, reports, and SOPs.
  • Ensure compliance with regulatory expectations and GDP in documentation.
  • Qualification of microbiological equipment, including autoclave qualification.
  • Prepare raw data trends and summary reports.
  • Perform bioburden testing and method validation.
  • Test and manage Biological Indicators.

Skills Required:

  • Viable Environmental Monitoring of classified and aseptic areas.
  • Proficiency in Bacterial Endotoxin Testing.
  • Expertise in Media Management, handling, and growth promotion testing.
  • Experience with microbiological failure management.
  • Knowledge in Equipment Qualification for microbiology labs (e.g., autoclaves).
  • Familiarity with raw data analysis and summary report preparation.
  • Experience in bioburden testing and method validation.
  • Strong documentation skills as per regulatory standards and GDP.

Additional Information:

This position demands a high level of technical expertise in microbiological testing and environmental monitoring, along with experience in documentation and compliance with regulatory standards.