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Api Adl Analyst

5+ years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: M.Sc. /M Pharma / PGD 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

Division: IPD

Department: IPD

Employment Type: Permanent


Job Purpose

Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units, and analytical laboratories by developing methods for raw materials, intermediates, and final APIs. Ensure drug development processes meet project timelines and comply with all regulatory requirements.


Key Accountabilities

  1. Method Development and Standardization:

    • Develop analytical methods and conduct routine analyses in a GLP-compliant environment.
    • Finalize specifications for molecule standardization and prepare for DMF (Drug Master File) submissions.
  2. Plant Query Investigation:

    • Investigate plant queries such as OOS (Out of Specification) and OOT (Out of Trend) results for quality control of drug substances and products.
    • Provide corrective actions and analyze samples for impurities.
  3. API Characterization:

    • Characterize final APIs and impurities to prepare test or working standards for routine laboratory use.
  4. Stability Analysis:

    • Conduct incubation studies and perform comprehensive stability analyses.
    • Determine storage, shelf-life, and packaging conditions for final APIs.
  5. Innovation and Continuous Improvement:

    • Stay updated on the latest innovations and applications in analytical techniques.
    • Apply advanced methods to resolve critical issues and improve existing processes.

Educational Qualification:

  • M.Sc. in Chemistry / M. Pharma / PGD

Relevant Experience:

  • Minimum 5 years of analytical experience in the pharmaceutical industry.

Job Location:

  • Bangalore

Competencies and Skills:

  1. Core Competencies:

    • Collaborate to Succeed
    • Innovate to Excel
    • Perform with Accountability
    • Lead with Empathy
    • Act with Agility
  2. Technical Skills:

    • Expertise in analytical method development and stability analysis.
    • Strong knowledge of regulatory and compliance requirements.
  3. Leadership and Management Skills:

    • Effective collaboration and problem-solving abilities.
    • Strong domain knowledge and capability to lead analytical investigations.