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Quality Assurance Consultant

Posted 24 Mar 2024
Work experience
1 to 3 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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De functie

ALTEN develops and delivers Life Sciences expertise to world-leading companies. Today ALTEN is a key player in Life Sciences (Pharmaceutical industry, Medical Devices…) with over 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 our team.

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.

Your main responsibilities are:

As a QA Consultant, you will integrate the life sciences team in the pharmaceutical industry and depending on your focus within the QA team at the client, you will have the following responsibilities:

  • 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.

Jouw profiel

As we are looking for multiple profiles (junior to senior level), earlier experience in the Life Sciences sector is an asset.

  • Understanding of cGMP and ISO regulation
  • Team player and communication skills
  • Accurate and critical mindset
  • Good analytical competences
  • Scientific or Engineering background preferably within the Biomedical Sciences, Pharmacy, Bio-Pharmaceutical Sciences or any other related background. A higher degree with relevant work experience is also considered.
  • Proficient in writing and communicating in English. Dutch is considered a plus.

ALTEN biedt

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 with the Life Sciences and pharmaceutical industry on the most recent technologies
  • Competitive salary package with attractive secondary benefits

ALTEN is als consultancy en engineering organisatie werkzaam in uiteenlopende (niche-)markten van de hightech sector en de IT. Kennis op het gebied van technologie speelt hierbij een belangrijkere rol, dé centrale pijler binnen ALTEN.
ALTEN zet haar specialistische kennis ook in op het gebied van IT. Kwaliteit en betrouwbaarheid, innovaties op het gebied van Big Data en Internet of Things, het zijn zaken waarin we een actieve rol spelen met toonaangevende partners.

Engineering
Capelle aan den IJssel
Active in 25 countries
800 employees
80% men - 20% women
Average age is 30 years

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