Shilpa Medicare Limited Job Vacancy For Quality Assurance (Clinical Trials)

Shilpa Medicare Limited Job Vacancy For Quality Assurance (Clinical Trials)

 Shilpa Medicare Limited Job Vacancy For Quality Assurance (Clinical Trials)

Requirement of Quality Assurance(Clinical Trials)

for Shilpa Medicare Limited.

Experience: 4-8 years

Department: Quality Assurance(Clinical trials)

Job Location: Nacharam, Hyderabad

Please share your CV to karthik.kumar@vbshilpa.com

Job Description :

Responsible for ensuring the quality and consistency of Clinical study audits and site Qualification audits of Hospitals and other Contract Research Organization for feasibility clinical studies.

Review of Draft Clinical study reports and raising of queries if any.

Provides training to new joiners based on the training plan.

Documentation distribution for departmental personal and new joiners.

Plays an active role in the preparation and conduct of internal audits.

Plays an active role in the preparation and conduct of vendor qualification audits for external outsourced activities.

Support to external health authority inspections.

Accountable for tracking change control and deviations to all SOPs or impacting and escalating issues.

Accountable for review of CAPA, maintain CAPA records and ensure the CAPA implementation.

Collates and reviews compliance data from cross functional departments, if applicable.

Archives documents according to prevailing standards.

Handling of Quality Management system.

Accountable for review or/and approval of all cross functional departments Standard Operating Procedures (SOPs).

Responsible for documentation and monitoring of incident, deviations investigation/ event reports.

Accountable for preparation of training program/ training log or training needs to all internal department personnel.

Please share your CV to Please share your CV to karthik.kumar@vbshilpa.com

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