Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain is executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality in order to help clients develop products safely, effectively, and quickly.

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Delivering the best is accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That’s why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.

Position: Quality Compliance – Clinical Trial

Location: Ahmedabad, Gujarat

Job Description:

  • QC work planning, creating QC plan/matrix for each study
  • Defining QC processes in study documents (plans) and ensure compliance of the QC program
  • Overviewing departmental processes to have systemic compliance assessment and plan enhancement. training and harmonization at the department level
  • Liaising with QA for sponsor system audit queries and regulatory queries/inspection findings

  • Overall QMS compliance within CTM and liaising with QA to ensure interdepartmental harmonization.
  • Study audit and system audit CAPA
  • Trend analysis of QC issues across studies, phases, stages, teams
  • Study protocol review for operational challenges and process perspective
  • Trending GDP / GCP issues/observation / Gaps and refresher training
  • Conduct quality control to ensure quality and compliance with SOPs, GCP, and project requirements.
  • Overviewing functioning of all project’s tools and software and track enhancement planning including excel trackers and CTM study templates
  • Regulatory Inspection readiness and local regulatory requirements compliance including quarterly and six-monthly updates
  • Deviation Management (system , Protocols and plan) and CAPA tracking and closure
  • Risk Identification, mitigation and overall systemic resolution tracking
  • Inputs in Site Selection based upon trend analysis
  • CTM SOPs creation and its management for timely revision including cross functional SOP inputs

  • System Audits CAPAs
  • GCP Helpdesk and harmonization of GCP / GDP understanding across team
  • Vendor performance evaluation and assessment for getting quality deliverables
  • Overall training monitoring for training plan compliance
  • Inspection readiness -Off-site checklists & on-site observations closure with evidences
  • Random sampling checks – key documentation across studies, processes, systems & software: gaps & reports

Qualification: B.Sc/B.Pharma, MS/M.Sc/M.Pharma

Experience: 10-15 Years

Salary: 14,00,000 TO 20,00,000 INR CTC/PA

Contact Details:

careers@lambda-cro.com

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