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Sr Officer - Qc

5+ years
Not Disclosed
10 Dec. 4, 2024
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 Summary

The Analytical Scientist in Quality Control is responsible for the analysis and handling of analytical instruments (HPLC, UV, SDS-PAGE, ELISA), performing stability studies, and conducting analytical method transfers and validations. The role includes maintaining compliance for analytical processes, ensuring readiness for internal and external audits, and supporting supervisors in managing OOS, deviations, and CAPA processes. The position requires coordination with cross-functional teams and ensures adherence to regulatory and internal quality standards.

Key Responsibilities

  1. Reagents & Sample Analysis

    • Prepare reagents and chemicals according to Standard Test Procedures (STP) and analyze batch samples, including in-process, hold time, and drug substances.
    • Conduct stability studies, analytical method transfers, and validations.
  2. Instrument Calibration & Maintenance

    • Calibrate instruments and equipment per defined SOPs and schedules.
    • Operate analytical instruments such as HPLC, UV spectrophotometer, gel pack, gel doc, and stability chambers.
    • Maintain instrument calibration in coordination with the engineering department.
  3. Analysis & Troubleshooting

    • Perform protein analysis using HPLC, UV, SDS-PAGE, and ELISA methods.
    • Identify, review, and compile Out of Specification (OOS), Change Control, Laboratory Incidents, and Deviations.
    • Collaborate with QA for effective closure of investigations and events.
  4. Audit & Compliance

    • Ensure lab readiness for internal and external audits at all times.
    • Participate in internal audits and ensure overall compliance with quality control standards.
    • Support supervisors in handling OOS, deviations, Out of Trend (OOT) results, and CAPA actions.
  5. Cross-functional Collaboration

    • Coordinate and communicate with cross-functional departments including Engineering, QA, Production, and Warehouse to ensure smooth operations and compliance.
  6. Additional Responsibilities

    • Assist the reporting manager or section supervisor with any other assigned tasks.

Skills & Competencies

  • Strong knowledge of biopharma products and analytical techniques.
  • Ability to troubleshoot analytical issues and collaborate with cross-functional teams for effective resolutions.
  • Strong communication skills, including reading, writing, and speaking, for effective interaction and reporting.
  • Experience with laboratory compliance and readiness for audits.