QA Professional for Qualification and Validation - Denmark
- Do you have interest and experience in qualification and validation of equipment, IT systems or processes?
- If so, then take the opportunity and join Quality Assurance (QA) of the Aseptic Production (AP).
About the department
- In QA AP, we are responsible of assuring quality and compliance in the Aseptic Production of insulin products in Site.
- It is our responsibility that the documentation related to AP is in compliance with regulatory requirements and the company quality management system.
- In QA AP, you will join a department of 43 highly motivated and dedicated employees which is divided into three teams, Operation, Aseptic Production and Projects.
- The vacant position is within the Project team.
- In a close collaboration with the production we ensure a high level of quality and play a key role in releasing insulin products to diabetics all over the world.
- As a QA Validation Professional, you will be a crucial factor in making sure that our released products meets the current GMP and regulatory requirements.
- You will be involved in qualification and validation of equipment, IT system and processes as well as the handling of incidents in the production.
- In 2017, we are working intensively with enhancing the level of compliance within data integrity and audit trail for our inspection lines as well as washing and sterilization of equipment.
- Furthermore, you will perform different tasks related to quality assurance, e.g. change requests and approval of production related documentation.
- We operate in a LEAN environment where we focus on optimizing our processes.
- On a daily basis, QA has close collaboration with the production which is based on an open and trusting communication.
- The job requires interacting with many key persons from production and management.
- You have five year experience in qualification and validation of equipment, IT systems or processes.
- Ideally, you are working in the Pharmaceutical industry and have production knowledge with good GMP understanding.
- Furthermore, you are holding an academic degree within e.g. Engineer, Pharmacist, Biochemist or similar.
- On a personal level you are seen as a team-player with a positive mind-set and interact with flexibility when needed.
- You have a strong quality mind-set, meet your deadlines and know how to prioritize between different tasks in a dynamic environment.
- You are good at coordinating different tasks for both yourself and other people and you demonstrate an ability to find the right solutions in collaboration with your colleagues.
- The spoken language in the team is Danish, but English at a higher level is needed.
Working with Us:
- Your skills, dedication and ambition help us to change lives for better.
- In exchange we offer you an opportunity to work with extraordinary talents and benefits from a range of possibilities for professional and personal development.