Job Vacancies for M.Pharm, M.Sc as Reviewer at 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 Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA), Fargo (USA) and Canada (Toronto), with a collective workforce of more than 1500 employees.

Post : Reviewer

Department : Bioanalytical - Bio-similar
Job Code : PBSRWR
Qualification : M.Sc. / M.Pharm / M.Tech (Biotech / Bio-chemistry)
Location : Ahmedabad
Years of Experience : 10 Years

Job Description
• Act as Reviewer for assigned Projects and Method Validation studies
• Work as study personnel in CLP studies and follow OECO CLP principles
• Review 100% study data and ensure that the raw data is in compliance with the Method SOP, Validation / Study Plan, Study Protocol and applicable internal SOPs
• Report any abnormal results identified during data review to Study Director or HOD/Designee
• Preparation of concentration tables for Pharmacokinetic and Pharmacodynamics analysis and data tables for Immunogenicity Assessment
• Coordinate with QC team for review of the raw data and resolve the project and method validation related OC findings
• Review/preparation of Method validation Reports
• Create / review new system SOPs or revise / review existing SOPs concerning departmental function
• Share timely status updates of Projects / Method Validation with Study Director

• Audit trait verification of software used in laboratory
• Review of correctness and completeness of uploaded documents in e-TMF
• Review of log-books as assigned
• Review lo ensure systems and practices in laboratory are as per widely used Lambda practices and systems and to bring any deviations to the attention of HOD or designee
• Tracking of departmental SOPs and maintaining master list
• Ensure validation of Software and Microsoft Excel files as required
• Perform vendor qualification for assigned vendor/service providers
• Develop self and maintain knowledge in relevant field at all limes