Regulatory Affairs & QA Specialist - Kemin industries

Overview

The RA/QA Specialist will be actively involved in helping to prepare international product registrations, ensuring regulatory compliance of product formulations, labels and literature and will be actively involved in the execution of Quality Management System duties.

We Are Kemin

We are visionaries who see things differently and are inspired by the world around us.  We have been dedicated to using applied science to improve the quality of life for over half a century.   We are a global ingredient manufacturer that strives to sustainably transform the quality of life every day for 80 percent of the world with its products and services.  

For over half a century, Kemin has been dedicated to using applied science to address industry challenges and offer product solutions to customers in more than 120 countries. Kemin provides ingredients to feed a growing population with its commitment to the quality, safety and efficacy of food, feed and health-related products to customers in more than 120 countries.   

Established in 1961, Kemin is a privately held, family-owned-and-operated company with more than 2,800 global employees and operations in 90 countries, including manufacturing facilities in Belgium, Brazil, China, India, Italy, Russia, San Marino, Singapore, South Africa and the United States. 

What you’ll be doing

Regulatory Affairs

• Creating and maintenance of registration documentation for EU/Africa/Asia;
• Providing regulatory expertise for veterinary biologicals;
• Anticipating and resolve key regulatory problems of global vaccine developments;
• Coordinating and/or conducting the preparation of new vaccine applications, coordinate and drive all type of EU regulatory procedures;
• Creating and maintenance of relevant regulatory documentation for veterinary biologicals for EU/Africa/Asia and Standard International Dossier (SID), e.g. expert reports, quality, safety and efficacy documentation, responses to questions;
• Creating, maintenance and/or reviewing of policies, EFPs, SOPs and guidance as needed;
• Assessing of regulatory documentation related to manufacturing and control, safety and efficacy of veterinary biologicals.

Quality Assurance/Quality Control Management

• Developing, leading and driving all QA aspects of Kemin’s projects;
• Ensuring appropriate quality issue management processes are established;
• Reviewing the data analysis and final reports for studies;
• Establishing and managing the tracking system for document control;
• Establishing, leading and managing the CMC development plan and lead the execution of the plan for vaccine substances and products from pre-clinical through commercial development.

What we expect of you

• Bachelor’s Degree (4-year degree) with at least 3 years of regulatory related experience and at least 3 years of quality assurance experience, preferably within animal vaccine development;
• Proven expertise with vaccine GMP Fluent in English and Arabic;
• Must be customer service-oriented and work well with varied personalities inside and outside of the corporation;
• Ability to read, write, handle basic math problems;
• Ability to manage projects;
• Strong written and oral communication skills;
• Analytical abilities;
• Extensive knowledge of MS Excel, Word, and PowerPoint software.

What’s in it for you

• A competitive financial package- in addition to your salary, we offer fringe additional benefits;
• Continued learning opportunities- Kemin recently launched a corporate university with online and in-person training opportunities for growth and development throughout your entire career;
• The chance to give back to our world- Through our foundation of servant leadership, we are proud to offer ample service opportunities. Kemin has a valued corporate partnership with both The World Food Programme and Habitat for Humanity, in addition to many local initiatives.

Apply Here