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7-10 years
Not Disclosed
15 June 5, 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, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Responsibilities:

  • Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation
  • Responsible for the quality oversight of GxP regulated computerized systems (e.g. manufacturing plant systems, laboratory systems and enterprise applications).
  • Manage the release of regulated systems for GxP production use
  • Participate in the review and approval of technical changes, Quality Incidents, CAPA's and procedures.
  • Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems.
  • Participate in evaluating the current Crucell quality systems for GxP computerized systems,and implement improvements to comply with the current FDA/EU standards.
  • Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU)
  • In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits.

Requirements:

  • Bachelor's or master's degree in science, computer science, or relevant area
  • English, fluently spoken and written.
  • Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries.
  • A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV
  • In-depth knowledge of computerized quality systems
  • Experience with GMP inspections