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Qa Lead

8+ years
Not Disclosed
10 April 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: QA Lead
Location: Banglore, Pune, Mumbai
Category: Regulatory/Compliance
Job ID: 25660


Summary of Responsibilities:

  • Collaborate with internal teams to address quality issues in the Quality Management System (QMS).

  • Monitor and track timeliness of cases within the QMS.

  • Assist teams in the creation and implementation of Corrective and Preventive Actions (CAPAs).

  • Maintain a thorough working knowledge of QMS functionalities and processes.

  • Liaise with QA Lead Manager and senior management regarding progression of quality cases and client notifications.

  • Support QA Lead Manager in collecting metric data, identifying trends, and tracking Quality Issues (QI).

  • Perform additional duties as needed or assigned.


Minimum Qualifications:

  • Bachelor’s degree in Life Sciences preferred, or equivalent life science experience.

  • Relevant and equivalent experience may be considered in lieu of formal education.


Minimum Experience Required:

  • 8 years of experience in a regulatory environment, preferably in GxP-compliant roles.

  • Strong understanding of QMS and CAPA procedures.

  • Effective teamwork and collaboration skills.

  • Ability to clearly communicate quality issues within the team and to clients as required.

  • Solid knowledge of Good Clinical Practice (GCP) and GxP standards.


Physical Demands / Work Environment:

  • Long periods of desk work and screen time.

  • Travel may be required.