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Manager Compliance

14+ years
Not Disclosed
10 Jan. 1, 2025
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: Manager Compliance
Date: Dec 25, 2024
Location: Halol 1 - Quality
Company: Sun Pharmaceutical Industries Ltd

Position: Manager Compliance
Experience: 14+ years in Microbial and Sterile Processing
Qualification: MSc / B.Pharm / M.Pharm

Job Description:

  1. Manage internal and external quality audits.
  2. Coordinate the pre-inspection process with the Cross-Functional Team (CFT).
  3. Lead the inspection team and Subject Matter Experts (SMEs) during inspections.
  4. Draft, facilitate, and ensure timely responses to inspections, and monitor Corrective and Preventive Action (CAPA) timelines.
  5. Monitor and track compliance actions arising from regulatory inspections, internal audits, and customer audits.
  6. Conduct self-inspections.
  7. Perform gap assessments based on new or updated regulatory guidance and regulatory observations.
  8. Possess knowledge and work experience in microbial and sterile processing.