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for Quality Control Lead

Company:
Nexgen Careers
Location:
Coimbatore, Tamil Nadu, India
Salary:
15000
Posted:
November 28, 2016
Description:

Hi All,

Greetings from Nexgen Careers

We have planned to conduct week drive Quality Control at Nexgen Careers,Coimbatore on 28-11-2016 to 03-11-2016.

JD:

Manages projects and conducts QC activities on deliverables produced by WSRO, WSS, and WRS ensuring accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations

Responsibilities/Authorities

Provides ongoing analysis of data resulting from the quality review of regulatory submission documents /ICSRs/ aggregate reports produced by WSRO, WSS, and WRS

Collaborates with MDL authors, epidemiologists, SER Management and others to develop strategies for the creation and collection of metrics data for quality analysis

Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives

Actively participates in the investment and strategy decisions related to the technology decisions related to Quality

Supports/promotes accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations

Knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidances

Provides support for regulatory inspections, internal audits and/or strategic quality initiatives

Manages special projects and senior management requests associated with safety compliance

Develops and maintains an understanding of ARGUS, Pfast, and case processing activities so as ensure the accuracy of ICSRs, aggregate reports, ad hoc reports and analyses, and safety query responses

Note: In case of selected in interview, Application charges will be applicable. (Charges

INR.850

Regards,

Dharshana

HR Recruiter

9655191116

Nexgen Careers

#60,2nd Street,

Indhu Nagar,

Vilankurichi Road.,Coimbatore-641 035