Suma Latha

About Suma Latha

A good working knowledge of GXP (GCP, GMP, GLP) Guidelines. Establish and maintaining…

Experience

1. Deputy General Manager-gcp Lead Auditor

   Accenture

   Dec 2023 — Present · Hyderabad, IN

   Audits & Inspections: Develop the Audit Schedule for the Fiscal year in agreement with the QGO Lead.Schedule and conduct audits, release/draft audits reports, approve CAPA responses and track CAPA actions to closure Monitor compliance to the audit schedule.Provide support and guidance as required during client audit / regulatory inspections.Provide support in performing RCA and drafting CAPA responses for Inspections/client audits and ensure timely closure of CAPA for inspections / client audits. Highlight risks and take appropriate actions (as required) in consultation with QGO lead / designee.2. Quality Management System (QMS) & Change Management:Implement/comply QMS procedures as per requirement specified in the Quality Manual, applicable Accenture policies and SOPs/Guidance documents.Develop SOP/Guidance documents for QGO.Review Standard Operating Procedures / Guidance documents developed by pharma projects.Maintain QA document repository.Provide training to pharma projects on GxP requirements Review request for changes, perform impact assessment and recommend actions as applicable in compliance with the applicable procedural documents.Review and confirm completeness of documentation for the change request and seek approval.3. Deviations/issues/CAPA management: Manage, track deviations/issues in compliance with applicable procedural documents and in consultation with the QGO Lead / designee.

Education

• TUV SUD

  ISO Certified Internal Auditor

  2012 — 2012

• Osmania University

  B.Pharmacy, English

  2003 — 2006

Skills

• Regulatory Requirements
• Validation
• Gcp
• Quality Control
• Sop
• Gmp
• Gxp
• Quality Assurance
• Quality System