Deviation Writer - Life Sciences

At Assystem Care, we embrace your most complex challenges and anticipate new regulatory and technology paradigms in the life science industry. Combining compliance & performance expertise with engineering, we break silos to optimize the time-to-market. We take care of your industrial processes from strategy to operations, so that you can focus on your patients and your core business. This is our way to contribute to transforming the Life sciences industry.

Our unique advisory offer integrates end-to-end engineering, quality and performance management throughout your whole industrial life cycle, with a transverse vision of systems engineering : from conception & engineering to batch release and operations optimization. Starting from your challenges, our team of experts develops the customized solutions you need based on our methodologies and our own first-of-a-kind smart tools.

In practice, to ensure the success of your project, our experts commit on results and duration with your team, focusing on 3 core axes:

  • Compliance & Performance of your operations, supported by continuous improvement and remediations projects via proprietary approaches & technical expertise.​
  • Engineering services & project management, using best-in-class risk management techniques suitable of your new and revamping industrial projects from design to validation​
  • Digital transformation, supported by data science, cybersecurity and knowledge management to secure your data and extract the needed insights for your business growth.

Our capability to integrate any solution and our systems engineering approach enable us to combine all these axes each time it is relevant.

 

Your Role :

Deviation writer within QC responsible of deviation management in production area and responsible to investigate the complaint of customer.

  • Management of deviations related to the activity in the building
  • Definition of corrective and preventive actions
  • Initiate and describe the deviation in SAP system.
  • Investigate process deviations to identify root-cause (operator interviews, 5Why’s, 6M, gembatour, …)  / Investigate Complaint
  • Propose adequate CAPAs.
  • Complete the deviation in SAP system, and collect annexes.
  • Generate standard KPI to follow the management of deviations.
  • Guarant of the deviation closure within delay.

 

Your Profile :

 

  • Pharmacist, bio-engineer, (micro) biologist, industrial engineer.
  • Experience of deviation management.
  • Knowledge of aseptic process.
  • Knowledge of good manufacturing practices, pharmaceutical production environment and deviation management system.
  • Experience in pharmaceutical or food industry; interested in microbiology and clean rooms; able to learn fast and in a structured manner
  • Good communication skills.
  • Good analytical skills; ability to investigate and ask questions, on the shopfloor.
  • Autonomous, Rigorous, Structured, Systematic.
  • Ability to work in team, multidisciplinary environment; lead and impact cross-functional team members
  • Quality oriented.

 

Our offer :

 

  • A salary in line with your experience
  • A competitive package of extra-legal benefits (car, fuel card, insurance, meal vouchers, entertainment expenses, ...)
  • Career opportunities both in Belgium and abroad
  • Clear objectives and challenges!
  • A people focused and motivating work environment