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Executive

3-7 years
Not Disclosed
10 Aug. 22, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 Summary:

Role: Executive
Department: Quality Control
Location: Unit 1
Educational Qualification: M.Sc
Experience Required: 3-7 years

Job Description:

  • Perform bacterial endotoxin testing.
  • Conduct viable environmental monitoring of classified and aseptic areas.
  • Manage and handle media, and perform growth promotion testing.
  • Address microbiological failures.
  • Maintain in-house and ready-to-use cultures.
  • Prepare specifications, Standard Testing Procedures (STPs), Technical Data Sheets (TDS), validation protocols, reports, and Standard Operating Procedures (SOPs).
  • Ensure documentation meets regulatory expectations and Good Documentation Practice (GDP) standards.
  • Qualify equipment used in the microbiology laboratory, including autoclave qualification.
  • Prepare raw data trends and summary reports.
  • Conduct bioburden testing and method validation.
  • Test and manage biological indicators.

Skills Required:

  • Viable environmental monitoring of classified and aseptic areas.
  • Bacterial endotoxin testing.
  • Media management, handling, and growth promotion testing.