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3-6 years
Not Disclosed
10 Dec. 27, 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 Title: CAPA Manager

Location: Mumbai

Job Function: Business Process Services

Role: Executive

Experience Range: 3 to 8 Years


Job Description:

TCS is hiring for the CAPA Manager position!

Responsibilities:

  • Experience in CAPA and Pharmacovigilance (PV) is highly valued.
  • Collaborate with both internal and external client departments to ensure proper development of CAPAs from internal quality audits and regulatory inspections.
  • Assist stakeholders in developing responses to audit, regulatory inspection, or process deviation observations.
  • Coordinate and set up meetings to expedite the CAPA preparation and closure process.
  • Ensure timely and effective closure of assigned CAPAs in collaboration with the Finding and CAPA Owners.
  • Track and monitor CAPAs with assigned stakeholders.

Skills Required:

  • Expertise in CAPA with a focus on Pharmacovigilance.
  • Experience working with SOP documents, audits, and inspections.
  • Proficient in tracking CAPA progress and monitoring timely closure.

Qualifications:

  • Required Qualifications: Bachelor's or Master's in Life Sciences (BPharm, MSc, MPharm, etc.).

Role Category: Business Process Services