Hatice Sava

Angestellt, QMS Manager, ib vogt GmbH
Berlin, Deutschland

Fähigkeiten und Kenntnisse

ISO 9001
Quality Management
Audit
FMEA
Quality Planning
Quality Management System
Corrective Action Planning
Standards Compliance
Audit Process Management
Root Cause Analysis
Compliance Requirements
Risk Assessment
Change Management
Internal Audits
Customer Complaints
Customer Satisfaction Questionnaires
CAPA
FSN
PNL
OOS
GMP Compliance
GLP
Quality Control Processes
Document Review
Inspection Protocols
Product Tests
Equipment Calibration
Raw Materials Analysis
Analytical skills
HPLC
GC
UV / Vis spectroscopy
AAS
FTIR spectroscopy
Method Validation
FDA Drug Safety Guidelines
Radiochemistry
Radiopharmaceuticals
Nuclear Pharmacy
Particle Counter
Field Office Management
Field Operations Reporting
Data Analysis
Oracle BI Reporting Tool
Microsoft Dynamics CRM Program
ISO

Werdegang

Berufserfahrung von Hatice Sava

  • Bis heute 1 Jahr, seit Juli 2024

    QMS Manager

    ib vogt GmbH

    Establish and maintain a Quality Management System (QMS) aligned with industry standards (ISO 9001) to ensure consistent product and service quality. Oversee quality management activities, including management reviews, audits, and company policies. Collaborate closely with the IT team to analyze internal processes and develop process flowcharts and descriptive documentation.

  • Bis heute 4 Jahre und 11 Monate, seit Aug. 2020

    Field Office Administrator and Quality Responsible

    Varian Medical Systems

    Represented the company in quality audits (ISO 9001) Managed the quality operations Created new SOPs Planned, performed, and reported internal audits of all departments Planned, performed, and reported Management Review Meetings Planned external audits Monitored the KPIs of all departments Identified and analyzed potential risks with department managers Trained all personnel regarding quality management program Managed the customer satisfaction surveys of all departments and managed customer complaints

  • 8 Jahre und 3 Monate, Mai 2012 - Juli 2020

    Quality Responsible & Operation Reporting Manager

    Varinak Oncology Systems Sales and Services

    Represented the company in quality audits (ISO 9001) Managed the quality operations Created new SOPs Planned, performed, and reported internal audits of all departments Planned, performed, and reported Management Review Meetings Planned external audits Monitored the KPIs of all departments Identified and analyzed potential risks with department managers Trained all personnel regarding quality management program Managed the customer satisfaction surveys of all departments and managed customer complaints

  • 2 Jahre und 4 Monate, Jan. 2010 - Apr. 2012

    Quality Control Specialist

    Eczacıbaşı - Monrol Nuclear Products

    Analyzed radiopharmaceutical products Followed up CAPAs and change controls with Quality Assurance Department Carried out R&D studies (Developing new analysis methods in HPLC and GC devices) Validated the product analysis methods used in laboratory Wrote validation protocols and reports Wrote stability protocols and reports Planned weekly workflow of the team (3 members)

  • 4 Jahre und 1 Monat, Aug. 2005 - Aug. 2009

    Quality Control Specialist

    Abdi İbrahim Pharmaceuticals

    Analyzed raw materials via using HPLC, GC, UV, AAS, Particle Counter, FTIR, etc. techniques and reported the test results Translated EP and USP Pharmacopeia analysis methods into Turkish and prepared SOPs Laboratory Training Responsible Gas Chromatography Devices Responsible MSDS Responsible

Ausbildung von Hatice Sava

  • 1 Jahr und 10 Monate, Sep. 2011 - Juni 2013

    Master of Science: Management in Pharmaceutical Industry

    Acıbadem University

Sprachen

  • Türkisch

    Muttersprache

  • Englisch

    Fließend

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