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Lambda Therapeutic Research
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Executive - Late Phase QA

Executive - Late Phase QA

Lambda Therapeutic Research

3 - 5 years

5 - 7 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

cro medical imaging compliance pharma project management quality systems trend analysis qa head clinical research auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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Executive - Late Phase QA