QA/QC in Clinical Research Associate-with Top Pharma Co, Navi Mumbai. job - Navi Mumbai,Maharashtra,India - Konnect HR Executive Search Firm

400,000 - 500,000 INR (PA)

Full Time

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Navi Mumbai,Maharashtra,India

Skills

"QA" "Quality Assurance" "QC" "Quality Control" "CRA" "Clinical Research Associate" "Trial Master File" "Clinical study report"

Experience: 4 to 6 Years
Industry: Pharma / Biotech / Life Science
Functional Area: Other

Job Specification:

1.Leading Quality Control team for completion of various project for various regulatory agencies

2.Reviewing data entry from the Case Record Form,Trial Master File & Clinical study report as per SOPs,protocol,regulatory standards & ICH GCP guidelines.

Candidate Profile:

1.Co-ordinating with the Project coordinator for pilot & pivotal bioequivalence studies initiation to the final eCTD report compilation & submission to QA and QC as per applicable SOPs.

2.Auditing respective area for compliance to SOP's & regulatory bodies.