Quality Assurance is an essential part of the product life cycle within the pharmaceutical industry. It is product, process or system oriented and is an independent entity within the company keeping oversight of all other departments to make sure all processes and procedures are followed, thus ensuring the final quality of the product.
As a QA Consultant, you will integrate the life sciences team in the pharmaceutical industry and you will have a part of following tasks, depending on your focus in the QA team:
- Responsible to set-up and maintain the quality management system in accordance with internal and external (inter)national standards and guidelines
- Process or system owner for various quality processes, such as change control, deviation and complaints handling, risk management, etc.
- Support the definition, set-up and implementation, in collaboration with the operational staff, of procedures to assure development and commercialization activities are conducted in accordance with internal and external (inter)national standards and guidelines
- Quality oversight of products; responsible for all document review and approval regarding changes to product design and production process, specifications, registration dossier, analysis methods, production methods, etc.
- Quality oversight of equipment, facilities and/or utilities; responsible for all document review and approval regarding changes to the production unit, validation and qualification studies, registration dossiers, etc.
- Quality oversight of suppliers or contract manufacturers; responsible for all document review and approval regarding changes of processes at the supplier, follow-up of ongoing corrective and preventive actions at the supplier, implementation of new materials or suppliers, control of incoming raw materials, components, etc.
- Responsible for auditing third parties to assure that processes used and/or data generated by these third parties meet all quality standards
- Responsible to provide support in preparation of and act as spokesperson during regulatory inspections
- Responsible for the coordination, investigation and follow-up of deviations and subsequent corrective and preventive actions, responsible for batch record review and final release of compliant product.
As we are looking for multiple profiles (junior to senior level), earlier experience in the Life Sciences sector is
- Team player and communication skills
- Accurate and critical mindset
- Good analytical competences
- Proficient to write and communicate in English
- Preferred background: Biomedical sciences, Pharmacy, Scientific master or PhD
- Proficient to write and communicate in Dutch & English
What we offer
At ALTEN we believe in growing together:
- Working within a Business Unit with ambitious growth, which will create a big network
- Human capital is our priority; we support our consultants’ career with follow-ups and close management
- The ALTEN Academy provides you certified trainings
- We give you the opportunity to work with leading companies on the most recent technologies, in addition to an attractive salary package.
About the organisation
ALTEN develops and delivers Life Sciences expertise to world-leading companies. Today ALTEN Belgium is a key player in Life Sciences (Pharmaceutical, Medical Devices…) with 30 clients. As a global player with a local presence, we are flexible and able to adapt to the needs of every single customer. That’s why we are looking for Quality Assurance Consultants to strengthen the team.