Lambda Therapeutic Research Ltd is looking to hire Quality Compliance -Clinical Trial .Interested and eligible candidates can send their resume.We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities….The eligibility criteria as follows.
Vacancy details :
|Company Name||: Lambda Therapeutic Research Ltd|
|Designation||:Quality Compliance -Clinical Trial|
|No. of Vacancies :||:01|
|Salary||: 14,00,000 – 20,00,000 PA.|
- 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
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