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Qa (Validation) - Executive

3-5 years
Not Disclosed
10 Feb. 10, 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

Position: QA (Validation) - Executive
Experience Required: 3-5 years
Location: Hyderabad
Employment Type: Full-Time


Job Responsibilities:

  1. cGMP Implementation:

    • Ensure the implementation and adherence to current Good Manufacturing Practices (cGMP) within the plant.
  2. Protocol and Report Preparation & Review:

    • Prepare and review validation protocols and reports to ensure compliance with regulatory standards.
  3. Quality Document Preparation:

    • Prepare essential quality documents such as the Validation Master Plan (VMP).
  4. Planner Preparation:

    • Create planners for calibration, VMP, and other relevant schedules to ensure timely validation activities.
  5. Validation & Qualification Execution:

    • Participate in the execution and verification of validation and qualification activities for equipment, instruments, utilities, and processes.
  6. Qualification Protocols & Reports:

    • Prepare and review qualification protocols and reports to ensure they meet the required standards.
  7. Drawing Layout Control:

    • Issue and control drawing layouts as part of validation and documentation processes.
  8. Asset and Document Allocation:

    • Allocate equipment, instruments, facilities, and document numbering for systematic tracking.
  9. Specifications & Stability Review:

    • Review specifications, stability protocols, and related reports to ensure compliance with quality standards.
  10. Document Storage & Retention:

  • Ensure proper storage, organization, and retention of validation and quality-related documents.
  1. Knowledge of Cleaning & Computer System Validation:
  • Possess knowledge of cleaning validation procedures and computer system validation (CSV).