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Reviewer Qc Microbiology

Zydus Healthcare Limited
Zydus Healthcare Limited
8+ years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time 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: Reviewer QC Microbiology
Location: Manufacturing-formulation, Goa, Panjim, Goa, India
Division: GOA QC
Posted: Feb. 12, 2025
Employee Type: P-P8-Probationer-HO Executive
Experience Range: 8-12 years

Responsibilities:

  • Review and approve test reports for raw materials, in-process samples, finished products, stability, calibration & validation, environmental monitoring reports from production and microbiology labs, microorganism identification (Vitek 2 Compact), biological indicators, BET, sterility, and water reports.

  • Approve analytical documents via LIMS.

  • Prepare protocols and summary reports for method validation of MLT, BET, sterility, and other miscellaneous studies.

  • Review qualification and validation documents.

  • Handle and investigate microbiological non-conformances such as OOAC (Out of Acceptable Control), OOAL (Out of Acceptable Limits), OOS (Out of Specification), and other errors related to microbiological incidents, including transcription errors.

  • Manage software systems such as LIMS, SAP, Ample Logic, DMS, etc.

  • Ensure adherence to cGMP and cGLP regulatory requirements, monitoring compliance via regular assessments.

This role offers a detailed and process-oriented opportunity for a professional with experience in microbiological quality control and regulatory compliance in a manufacturing setting.