E- Compliance Specialist

Abdi İbrahim İlaç Sanayi ve Ticaret A.Ş.

Abdi İbrahim, founded in 1912, has the largest product portfolio in the sector and is the largest employer in the Turkish pharmaceutical industry with 4750 employees. Abdi İbrahim has been the leader of Turkey’s pharmaceutical industry since 2002 with its powerful vision. Today, Abdi İbrahim exports more than 60 countries. As a corporate citizen working towards creating a better world and a better future, adhering to its mission in the sector and to the requirements of societal priorities, Abdi İbrahim focuses on sustainability in all its business processes. Its vision for 2025 - apart from maintaining its status as a wholly local company - is to become "one of the top 100 pharmaceutical companies in the world.

Job Description

• Quality oversight of operational activities of GxP systems (e.g., Changes, , Deviations etc.,)
• Provide needed support to meet the applicable regulatory requirements for GxP regulated computerized systems.
• Act as point of contact between IT and Business for eCompliance topics
• Promoting a Quality Culture.
• Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
• Review and approve the GxP Changes and the associated deliverables.
• Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
• Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps
• Provide Audit support as assigned and in case of CAPAs, provide the required Quality support.

Qualifications

• Degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent
• Advanced level of English (oral and written)
• Experience in quality management systems
• Understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, 21CFR11, Annex11,etc.)
• Experienced in the operational management of GxP to support the operation