Sibel U.

About Sibel U.

OBJECTIVE & SKILLS A highly motivated and focused Quality Professional who has…

Experience

1. Internal Audit Manager

   Repligen Corporation

   Mar 2022 — Present · Waltham, MA, US

   The Internal Audit Manager• Ensures and promotes compliance through the management of manufactured products and processes for Repligen Corporation based on ISO 9001 Standard. • Harmonization of processes globally, and training for auditors• Review applicable ISO 9001:2015 standards, cGxP, GDP and regulations to ensure adherence and compliance• Develop and maintain a risk-based auditing program supporting Internal Audit initiatives, continuous improvement, and regulatory compliance to improve operations efficiency at Repligen. • Perform and manage Internal Audits • Prepare Audit Agenda including scope, objectives, reviewing previous Corrective Actions for closure and any safety concerns • Prepare, complete, and approve audit reports • Communicate audit information to cross functional teams and auditee(s) in a timely manner• Create and update the internal Audit schedule accordingly• Perform annual review of the Internal Audit Program• Maintain Internal Audit files• Promptly escalate and report all critical audit findings to senior management• Support KPI activities and derive strategic decisions from the data related to the program• Support Customer Audits and evaluate findings/observations

Education

• Istanbul University, Istanbul, TURKEY

  BSc, Metallurgical and Materials Engineering, Distinction

  1997 — 2001

• University of Strathclyde, Glasgow, UK

  MSc, Mechanical Engineering: Energy Systems and the Environment, 2:1

  2008 — 2009

• USDA Graduate School, Washington DC, USA

  Marketing Techniques for the 21st Century, Grade:A

  2002 — 2002