Instagram
youtube
Facebook

Group Leader Quality Assurance - Clinical Qa

8-10 years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Remote 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: Group Leader Quality Assurance - Clinical QA
Date: Feb 6, 2025
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 55040

Company Overview

Teva Pharmaceuticals is on a mission to make good health more affordable and accessible, helping millions around the world live healthier lives. We are the world’s leading manufacturer of generic medicines, and we are proud to produce many of the products on the World Health Organization’s Essential Medicines List. Over 200 million people worldwide take one of our medicines every day. Join us in making a meaningful difference in global health.


Job Responsibilities

  1. Quality Management System (QMS)

    • Ensure that processes needed for the Quality Management System are established, implemented, and maintained at WPPL.
    • Report on the performance of the QMS to the Head-QA, contributing to the improvement of the system.
  2. Clinical Activities and Audits

    • Plan and execute clinical activities, ensuring that data from the clinical phase complies with relevant SOPs and current GCP/GLP guidelines and protocols.
    • Conduct general and system audits across all departments.
    • Review equipment installation, qualification, calibration, and preventive maintenance in the clinical department, ensuring these activities are conducted as per schedule.
  3. Clinical Study Review

    • Review pharmacokinetic data, statistical analysis, and clinical study reports, ensuring they meet required standards.
    • Review statistical analysis reports for In-Vitro Binding Studies.
    • Review raw data from clinical projects as assigned.
  4. External Vendor Audits

    • Conduct external vendor audits to ensure compliance with standards.
  5. Compliance and Risk Management

    • Conduct internal study and system audits to check for compliance with GCP/GLP, protocols, SOPs, and applicable regulatory requirements.
    • Review and evaluate the impact of change controls, deviations, and CAPAs.
    • Conduct facility/risk-based assessment audits at clinical and pathology laboratories for BA/BE studies at WPPL.
  6. Data Management and Review

    • Review SDTM data and its flow from QA to the SDTM team.
    • Ensure the timely delivery of data and reports for statistical analysis and clinical study reports.
  7. Regulatory Inspections and Audits

    • Support the Head-QA during regulatory and sponsor inspections/audits at WPPL.
    • Review responses to regulatory and sponsor queries.
    • Ensure that CAPA actions based on investigation results are identified and implemented.
  8. Policies and Documentation

    • Review and update Policies, Quality Manual, and Site Master File at WPPL.
    • Review and update SOPs and work documents at WPPL prior to approval.
  9. Other Responsibilities

    • Conduct monitoring of studies at external CROs as assigned.
    • Sign as designee for Head-QA on all controlled documents in the Head-QA’s absence.
    • Hold meetings with clinical and pathology departments to update them on the quality system.
    • Carry out other duties as assigned by the Head-QA.

Qualifications

  • Education:

    • M.Sc, M.Pharm, or Ph.D.
  • Experience:

    • 8-10 years of experience in Clinical Quality Assurance for BA/BE studies.