Quality Improvement Project Lead (Regulatory)

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 4750employees. 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.

QUALIFICATION

·       Bachelor’s degree required in a field such as Chemistry, Biology, Pharmacy or equivalent,

·       US FDA ANDA Filling Experience,

·       Strong understanding of ANDA Filing & Submission Process,

·       Excellent research and analysis skills especially in terms of understanding US FDA ANDA review policies and requirements,

·       Experience reading and interpreting FDA regulations and sub-regulatory guidance,

·       Advanced Project Management skills combined with a structured and solution-oriented work approach,

·       Capable of working collaboratively in a team environment,

·       Strong personal integrity, patience, discretion, and maturity,

·       Strong Leadership and Stakeholder management skills,

·       Experienced with Quality Systems, (GMP)

·       Excellent communication skills and interaction with all kinds of internal and external interfaces,

·       Fluency in English, 

JOB DESCRIPTION 

·       Project Lead for FDA Inspection Readiness Project.

·       Key contact for Regulatory Affairs, R&D CMC, Quality CMC & RA Compliance project groups.

·       Key contact for Consultants. Planning & Follow Up of consultancy programme.

·       Lead all activities related gap analysis and capa follow up.

·       Coordinate all project related activities according the needs and priorities.

·       Organize routine follow up meetings with SMEs to monitoring of the actions.

·       Periodic reporting about project status.

·       Support to SMEs for their development programme.