Research Executive / Associate - Quality Assurance Post Vacant @ Lambda Therapeutic Research Limited
Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mumbai (India), Toronto (Canada), Warsaw (Poland), London (UK) and USA. Lambda offers full spectrum clinical trial solutions empowered by more than 14 years of service to the biopharmaceutical and generic industry. At Lambda, our comprehensive services are 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
Job Title : Research Executive / Associate – Quality Assurance
Eligiblity : M.Sc – Bio-Chemistry, Chemistry, Microbiology, M.Pharma – Pharmacy
Experience : 2 – 4 yrs
Location : Ahmadabad
Job Description :
Job Title : Research Executive / Associate – Quality Assurance
Eligiblity : M.Sc – Bio-Chemistry, Chemistry, Microbiology, M.Pharma – Pharmacy
Experience : 2 – 4 yrs
Location : Ahmadabad
Job Description :
- Plan and carry out In-process audits of study activities in Clinical Pharmacology & Medical Affairs department like, dosing, meal distribution, phlebotomy, sample separation, dispensing, etc.
- Conduct retrospective audits of trial master file, study related clinical raw data like Case Record Forms, General Case Record Forms and IMP documents, log book verification.
- Conduct retrospective audit of Clinical Study Report
- Conduct system audits as per schedule, prepare audit report and ensure compliance in Clinical, phase 1, pharmacy, screening, sample separation & medical writing/report writing department.
- Review of investigation report.
- Review of sponsor comments related to clinical study reports & raw data
- Train CPMA auditors (New joiners) for in process audit of study related activities
- Conduct audits of vendors who are service providers to assess compliance to Quality System at their end.
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