Job Title:  Executive - Late Phase QA

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research is a Global full-service Clinical Research Organization (CRO) with its headquarters in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK) and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to the global innovator, biotech, and generic pharmaceutical industries.

JOB DETAILS

• To  determine  whether  all  trial  related  activities  were  conducted,  data  recorded,  analyzed  and  reported accurately  &  in  compliance  to  all  applicable  Regulatory  requirements,  Organizational  requirements  (Policy, Procedures and processes) and Client’s requirements (protocol, contract etc.) by routinely conducting  audits (In process, on-site and off-site) at various stages for all assigned projects
• Performing & reporting of system audits as per system audit annual calendar to ensure compliance w.r.to Lambda SOPs, Quality Systems, Protocol and applicable regulatory requirements
• Support Head-QA/Designee for handling regulatory inspections, Sponsor system audit, arranging data for regulatory inspection, Sponsor system audit
• Provide  Audit  and  inspection  support  for  assigned  projects  including  where  feasible,  advising  the  project team during preparation and conduct of external audits and inspection
• To perform retrospective audits of study related raw data like Informed Consent Forms, protocol, project management  plan  and  associated  Plan,  IMP  plan,  IMP  release  checklists,  Safety  Management  Plan (SMP),  Clinical Study Report, Medical Imaging related documents
• Prepare  and  review  of  QA  SOPs,  review  of  system  SOPs  (CTM,  MI,  CTM-MS)  and  working  instructions  of other department (Clinical Trial Management) for correctness, adequacy and compliance
• After  completion  of  all  the  stages  of  audit  for  undertaken  clinical  trial,  prepare  the  risk  analysis  of observations and suggest mitigation plan to concerned department and to share the report with management
• To review and provide inputs to sponsor query responses and facilitate regulatory inspections at site in conjunction with operation team (as applicable)
• Planning and communications for On-site audit for all applicable projects, vendor audit Management
• Compilation  of  the  data  and  updation  of  internal  tracker/database  at  regular  interval  to  perform  trend analysis
• Audits of Trial Master File, Site Master File, Protocol deviation tracker and SAE tracker at various stages of the clinical trial
• Update Head-QA/Designee regularly on the level of compliance and compliance issues

EXPERIENCE

• 3-5 years

EDUCATIONAL QUALIFICATION

• M.Pharm