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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 6 Years


Job Description:

TCS is hiring for the position of CAPA Manager!

Responsibilities:

  • Candidates with experience in CAPA and Pharmacovigilance (PV) are highly preferred.
  • Collaborate with internal and external client teams to oversee and ensure the proper development of CAPAs from internal quality audits and regulatory inspections.
  • Assist stakeholders in developing responses to audit, regulatory inspection, or process deviation observations.
  • Organize and coordinate 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 and ensure CAPA effectiveness checks are completed.
  • Create metrics and slide decks to visualize progress and challenges and perform trend analysis as required.
  • Monitor due dates to ensure timely closure of deviations and associated CAPAs. Support the development of suitable extension or modification plans when necessary.

Skills Required:

  • Experience with CAPA and Pharmacovigilance.
  • Strong knowledge of SOP documents, audits, and inspections.
  • Proficient in monitoring CAPA effectiveness and tracking due dates.
  • Ability to perform trend analysis and create reports for stakeholders.

Qualifications:

  • Required Qualification: Bachelor's or Master's in Pharmacy, Life Sciences, or related fields (BPharm, MSc, MPharm, etc.).

Role Category: Business Process Services