Spécialiste en assurance qualité

Il y a 8 heures

Aalst, Flanders, Belgique Akkodis Temps plein

About Akkodis

Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.

Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com

Key Responsibilities

  • Ensure the implementation, maintenance and continuous improvement of the Pharmaceutical Quality System in compliance with EU GMP, GDP and company quality standards.
  • Review, approve and maintain GMP documentation, including SOPs, work instructions, protocols, reports, specifications and batch documentation.
  • Manage quality events such as deviations, CAPAs, change controls and investigations, ensuring timely assessment, follow-up and closure.
  • Support qualification and validation activities through documentation review and quality oversight.
  • Participate in risk assessments, quality improvement initiatives and contamination control activities where applicable.
  • Ensure supplier and material quality management through supplier qualification, change assessments, complaint handling and quality agreement support.
  • Monitor GMP compliance within operations and provide quality support to manufacturing, laboratory, engineering and supply chain teams.
  • Support internal audits, customer audits and regulatory inspections, including preparation, execution and follow-up of observations and action plans.
  • Monitor quality KPIs, identify compliance risks and escalate critical quality issues when required.
  • Promote a strong quality culture and provide guidance on GMP and quality requirements across cross-functional teams.
  • Contribute to training activities and support continuous improvement initiatives within the Quality organization.
  • Support data integrity principles (ALCOA+) and ensure compliance with applicable regulatory expectations.

Required Profile

  • Master's or Bachelor's degree in Pharmacy, Chemistry, Biology, Biotechnology, Biomedical Sciences or a related scientific discipline.
  • Minimum 5 years of experience in Quality Assurance within the pharmaceutical, biotechnology or life sciences industry.
  • Strong knowledge of EU GMP regulations, GDP requirements and pharmaceutical quality systems.
  • Proven experience managing deviations, investigations, CAPAs, change controls and risk assessments.
  • Experience reviewing and approving GMP documentation and supporting validation and qualification activities.
  • Familiarity with supplier quality management, audit support and inspection readiness activities.
  • Knowledge of data integrity principles (ALCOA+) and regulatory expectations.
  • Experience working with electronic Quality Management Systems (eQMS), such as Scilife, Veeva, TrackWise or equivalent.
  • Strong communication and stakeholder management skills, with the ability to interact effectively across Quality, Production, QC, Engineering and Supply Chain departments.
  • Autonomous, structured and solution-oriented mindset with a strong attention to detail.

What we have to offer

At Akkodis, we want to give you the right environment to develop your expertise and grow throughout your career. You can count on:

  • A permanent contract
  • An attractive compensation package, including 13.92 months of salary
  • A company car or mobility budget, depending on your package
  • A flexible cafeteria plan
  • Hospitalization insurance
  • Training and development opportunities to strengthen both your technical and professional skills
  • A structured onboarding and regular follow-up, including career discussions and support from your managers
  • Access to technical communities and experts to exchange knowledge and develop your expertise
  • Referral and business bonuses when you contribute to growing our teams and business
  • Opportunities to develop your career across different projects, technologies, and areas of expertise