Opening to work as Associate QA & QC in NexusCRO

NexusCRO is a leading full service clinical research organization (CRO) committed to empowering its clients with the knowledge to bring products to the market quickly and easily with proven expertise in supporting global clinical trials for pharmaceutical and biotech companies. We provide clients with customized services from initial strategic planning through regulatory submissions and approval.(Global IQ) NexusCRO’ score competencies are in product agency registration support, trial design, site selection, project management, medical and site monitoring, data management, biostatistical analysis, pharmacovigilance, medical writing, metrics development and full clinical trial management and consulting services. We are dedicated to ensuring that each clinical trial is executed to the highest possible standards. For companies worldwide, Nexus is a trusted partner in clinical research

Post: Associate QA & QC

No. of Posts: 02

Job Description:
- Reviewing study specific documents including Study Protocol, Informed Consent Document/Form, Case Report Form in compliance with ICH-GCP, Schedule Y and CDSCO guidelines.
- Preparation for relevant SOPs and review as per the current regulatory requirements.
- Online monitoring review of data, ensuring resolving of errors and inconsistencies in order to ensure quality of the study.
- Review of drug product receipt, drug dispensing and retention forms.
- Implement QA systems and generate SOPs

Candidate Profile:
M.Pharm, B. Pharm, Diploma in Clinical Research.
Experience: 0-2 years

Additional Information:
Qualification: B.Pharm, M.Pharm
Location: Navi Mumbai
Functional Area: QA, QC
End Date: 7^th April, 2016