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Position: Clinical/GCP QA

Location: Vadodara/Baroda, Gujarat

Job Description:

  • Support, facilitate and execute outsourced BA/BE studies audit program (patient-based studies & healthy volunteer studies) which include investigator site audits, study audits (conducted at CROs), Trial Master File (TMF) audits, study documents audits, systems/processes audits, etc. in order to identify gaps and areas of improvement for compliance to agreed study documents, applicable regulations, and guidelines. Monitor the creation of appropriate Corrective Action and Preventive Action (CAPA) plan and its execution to meet the necessary compliance standards.
  • Verify adequacy of all created & executed CAPAs.
  • Develop and manage a GCP QA oversight/audit program for outsourced parties (CRO, Vendors, Service Providers, etc.) associated with R&D QA activities.
  • Prepare audit reports within a timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the upper management.
  • Provide QA oversight in the creation of study documents (e.g. study protocol, ICFs, etc.) in compliance with applicable guidelines, regulations, and Good Documentation Practice (GDP).

  • Facilitate and coordinate, in collaboration with other R&D stakeholders, handling of regulatory inspection. Support creation and implementation of appropriate CAPA for the identified gaps and resolution of regulatory queries in a time-bound manner.
  • Evaluate current systems & processes and create (review and/or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) in collaboration with relevant stakeholders to ensure R&D activities for outsourced BA/BE studies (patient-based studies & healthy volunteer studies) comply with the appropriate GxP requirements.

Qualification: B.Pharma, MS/M.Sc/M.Pharma

Experience: 10-14 Years

Salary: Negotiable

Contact Details:

Mr. Vignesh Iyer

vignesh.iyer@sunpharma.com, hrd@sunpharma.com

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