Lambda
Therapeutic Research Ltd Hiring QUALITY COMPLIANCE CLINICAL
TRIAL B.Pharma / Any Science Graduate / Post Graduates
Roles
and Responsibilities
QC
work planning, creating QC plan / matrix for each study
Defining
QC processes in study documents (plans) and ensure compliance of QC program
Overviewing
departmental processes to have systemic compliance assessment and plan
enhancement. training and harmonization at department level
Liaising
with QA for sponsor system audit queries and regulatory queries / inspection
findings
Overall
QMS compliance with in 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 re-fresher 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
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