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3-8 years
Not Disclosed
10 Dec. 19, 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 Role: CAPA Manager
Experience: 3 to 8 Years
Location: Mumbai
Qualification: Any Life Science Graduate
Skills: CAPA, Pharmacovigilance, SOP Documents, Audits & Inspections, Quality Analyst

Job Description:
TCS is hiring a CAPA Manager for its Mumbai location. The role involves:

  • Collaborating with internal and external teams to oversee and ensure proper development of Corrective and Preventive Actions (CAPAs) resulting from internal quality audits and regulatory inspections.
  • Supporting stakeholders in preparing responses to audit, regulatory inspection, or process deviation observations.
  • Coordinating meetings to expedite CAPA preparation and closure.
  • Ensuring timely closure of CAPAs in collaboration with CAPA owners and stakeholders.
  • Tracking and monitoring the progress of CAPAs with assigned stakeholders.

Skills Required:

  • Experience in CAPA and Pharmacovigilance (PV).
  • Knowledge of SOP documents, audits, and inspections.
  • Strong coordination, communication, and organizational skills.

Desired Qualifications:

  • Bachelor’s/Master’s in Pharmacy, Science, or related fields.

Job Function: Business Process Services
Role: Executive
Job ID: 341299