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Executive - Quality Control

2+ 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

Position Title: Quality Control Analyst – Analytical (HPLC, UV, & Other Techniques)
Department: Plant
Company: Sun Pharmaceutical Industries Ltd
Location: Bangalore

Main Purpose of the Job

The Quality Control Analyst will be responsible for the handling and analysis of analytical instruments such as HPLC, UV, and other techniques, while ensuring compliance with internal and regulatory audit requirements. The role includes batch sample analysis, stability studies, method transfer/validation, and maintaining laboratory readiness for internal and external audits.

Job Responsibilities

  1. Analysis & Documentation

    • Prepare reagents and chemicals as per Standard Test Procedures (STP).
    • Perform analysis on batch samples (in-process, hold time, and drug substance) and stability studies.
    • Conduct analytical method transfers and validations.
    • Ensure proper documentation for all activities.
  2. Instrument Calibration & Maintenance

    • Calibrate instruments and equipment according to SOPs and defined schedules.
    • Perform protein analysis using HPLC, UV, SDS-PAGE, and ELISA methods.
    • Ensure calibration maintenance in coordination with the engineering department.
  3. Operational Tasks

    • Operate HPLC, UV spectrophotometer, gel pack and gel doc, stability chambers.
    • Identify, review, and compile Out of Specification (OOS), change control, and laboratory incidents.
    • Participate in internal and external audits, ensuring laboratory readiness at all times.
  4. Compliance & Investigation Support

    • Report and comply with laboratory events, OOS, deviations, incidents, and changes.
    • Assist the supervisor in handling OOS, Out of Trend (OOT), deviations, and CAPA with proper action plans through Trackwise System.
  5. Cross-Functional Coordination

    • Collaborate with Engineering, QA, Production, and Warehouse departments for smooth operations.
    • Contribute to the closure of investigations and events in collaboration with QA.
  6. Other Duties

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

Skills & Competencies

  • In-depth knowledge of biopharma products and analytical techniques.
  • Strong troubleshooting and problem-solving skills within a team setting.
  • Excellent communication skills (reading, writing, speaking) for effective collaboration and deliverables.