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Manager

10+ years
Not Disclosed
10 Dec. 4, 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 Responsibilities

  • Oversee lifecycle management of development products in line with ICH guidelines, including knowledge management and process changes in early phase development.
  • Review clone development, cell banking documentation, and ensure compliance with regulatory requirements for plans and reports.
  • Evaluate product development documents, including process development reports, process descriptions, and process control strategy documents.
  • Assess analytical development documents, such as method development, qualification/validation protocols, and reports, ensuring compliance with current quality and regulatory standards.
  • Develop, implement, and continuously improve the Quality Management System (QMS) in R&D through SOPs, manuals, training, and audits, ensuring alignment with corporate QA and site QA.
  • Verify laboratory data integrity, adhering to good documentation practices and data reporting per ALCOA++.
  • Compile and review process and analytical documents for regulatory filings and CMC reviews.
  • Control and manage documents, including the issuance of working copies, verification of raw data, and archival of documents in both soft and hard copy formats following ALCOA+ principles.
  • Stay updated on regulatory requirements for Biosimilars and biologics, with a focus on USFDA, EMEA, Japan, India, and other markets.
  • Lead dossier writing for multiple regulatory agencies, including USFDA, EMEA, and India.
  • Maintain audit readiness and effectively respond to audit queries from regulatory agencies, clients, and business partners.

Education and Experience

  • Education: MSc in Life Sciences or M. Pharm (Quality)
  • Experience: Minimum 10-15 years in Quality Assurance, with strong knowledge of regulatory guidelines (RCGM, CDSCO, ICH, ISPE).
  • Preferred Experience:
    • Exposure to product development, analytical development, CMC, regulatory filing, and regulatory requirements for recombinant products.
    • Experience in filing for regulated markets (EMA/FDA/PMDA/TGA/HC/ANVISA) and lifecycle management for global product development.
    • Experience in international inspections/audits from regulatory agencies and business partners.
  • Skills: Excellent verbal and written communication skills in English, and experience in dossier writing.