Ahmet Yanar

Berufserfahrung von Ahmet Yanar

• Bis heute 1 Jahr und 6 Monate, seit Jan. 2023

  Head of Quality Unit and QP

  Artesan Pharma GmbH & Co. KG

  Leading the site QP, QC, QA and Validation/Qualification organisation at Artesan Pharma Lüchow-Dannenberg, full-service partner in the pharmaceutical industry for contract development and -manufacturing. As part of the Klosterfrau Group, Artesan Pharma manufactures at 4 production sites in northern Germany and supplies the European and international markets with solid forms, lozenges, sterile single use syringes and liquid drug products.

• 2 Jahre und 3 Monate, Okt. 2020 - Dez. 2022

  Head of QA Systems and Audits, Qualified Person

  Aspen Bad Oldesloe GmbH

  As a Qualified Person, certification of sterile, solid liquid and semisolid medicinal products and imported sterile medicinal products for the EU market Coordination of authority audits at non EU production site to gain EU GMP certification Responsible person for narcotics according to BtmG § 3 Head of a team of QA experts responsible for PQR preparation, GMP risk assessments, auditing, supplier qualifications, inspections, CAPAs, Change Control

• 3 Jahre und 11 Monate, Nov. 2016 - Sep. 2020

  Qualty Assurance Manager and Qualified Person

  Helm AG

  QP certification of drug products (incl. narcotics) Control and release of medical devices Lead GMP auditor for API and DP manufacturers, QC laboratories Planning and execution of internal inspections Assurance of GMP compliance in project teams for new developed products Management and monitoring of internal and external (CMO) change control processes Preparation, control and approval of GMP relevant documents Conduction of regulatory inspections and customer audits

• 3 Jahre und 10 Monate, Nov. 2012 - Aug. 2016

  Quality Assurance Manager and Qualified Person

  Sandoz Gruppe / HEXAL AG (a Novartis company)

  Deputy Head of Quality Assurance Materials Batch Release sterile APIs and oral antibiotics, excipients, raw materials and packaging materials Regulatory inspections (AGES, US-FDA, ANVISA) Supplier Management Creation and update of quality agreements Audit of API, excipient, raw material and packaging material manufacturers and suppliers Creation and update of SOPs Approval of deviation and OOS investigations