Process Validation Supervisor

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.

We are looking for a Process Validation Supervisor for our Esenyurt Campus;

Job Description

• Providing technical direction to core teams and act as customer-facing lead for project teams
• Managing the scope, schedule, and reporting of PV program activities for individual products and/or clients; ensure status, risks, and open issues are tracked and that all stakeholders are informed of changes
• Designing PV studies to meet the stated intent including development of acceptance criteria
• Ensuring that all validations are performed according to the regulatory, site and customer requirements
• Being an expert for the validation of aseptic process (preparation, filling, filtration, holding times etc.
• Author validation documentation of Process Validation protocols and reports
• Investigating deviations as per need and execute corrections and/or develop preventive actions
• Defining and execute improvement projects and initiatives in order to improve process validation and customer/site support
• Interacting in a professional way with all the clients in order to decide the best validation strategy for each client drug transfer
• Participating in customer and regulatory audits
• Ability to compute, analyze, and interpret complex statistical data
• Coaching of Process Validation Specialists

Qualifications

• Minimum of 7 years of experience in the pharmaceutical industry, with a relevant experience in a sterile and/or solid production environment
• Minimum of 2 years’ experience in a process validation role
• Strong understanding of current global regulations related to process validation and understanding of the applications. Experience with regulatory inspections is a plus
• Knowledge of Good Manufacturing Practices and statistical methods used for Pharmaceutical Process Analysis
• Fluent in English