Raptim Research Pvt Ltd Jobs | Clinical Trials QA Vacancies

About Raptim Research Pvt Ltd:

Raptim Research Private Limited (formerly known as Raptim Research Limited), is a global independent and internationally accredited Contract Research Organization (CRO), established in 2005 with state-of-the-art clinical research facilities in Mumbai and Gandhinagar (India).

Raptim Research is a full-service provider focused on early and late-phase clinical research services with 15 years of experience. Our support services include large and small molecule Bio-analysis, Clinical Pharmacology, In-vitro Studies, Feeding Tube Studies, BCS Biowaiver studies, Data Management, Biostatistics, Regulatory Support, and Project Management.

OUR VISION

To achieve the fastest path to regulatory, scientific and clinical approvals of drugs, biologics, and medical devices while maintaining the highest ethical and scientific standards.

OUR MISSION

Our goal is to become the leader in Clinical Research, to achieve a wider reach to customers with unmatched service quality, to remain committed to our Human Care Management and to continue to garner more international regulatory approvals as we strive for a greater global presence.

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About Raptim Research Pvt Ltd Vacancies:

We have an urgent opening in the Clinical Trials QA team.

Req. Experience: 3 to 8 Years of relevant exp.
Qualification: M. Pharm. / B. Pharm.
Job Description:
·        In process and Retrospective Audit of Studies.
·        Internal / System, Vendor and Facility Audit and review of agreements.
·        Issue and Control of documents.
·        Archival and Retrieval authorization of documents.
·        Review of Source Documents, Study files and CRF’s of the study.
·        Review of Study / Clinical Trials Protocols and Reports.
·        Review of Deviations and its CAPA.
·        Review of Statistical Data.
·        Internal audits / System audits and Data Review at the Trial site.
·        Preparation and Review of Clinical Trials SOPs/ Documents.
·        Preparation and Issue of audit reports.
·        Review of Clinical Trials related Plan, and Procedure as per scope.
·        Conduction of Vendor Audit as per schedule.
·        Compliance Verification of audit responses and Closure
·        Assisting Head Quality Assurance in Sponsor and Regulatory audits

Interested candidates please share your resume on rakesh.talwatkar@raptimresearch.com or call on 8591708707.

Thanks & Regards,

Rakesh Talwatkar

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