Deviation Writer - pharmaceutical

Assystem Group is an international and independent engineering company. Assystem has been supporting and managing challenging projects and deploying cross-functional expertise across key industrial sectors like nuclear, energy, oil & gas, infrastructure, transport, automotive, aerospace, life-sciences... The group employs over 12,000 engineers in continental Europe, UK, GCC, North America, Africa, India and Southeast Asia and in 2015 had revenues of 1.4 billion USD.

Assystem opened a subsidiary in Belgium in 2009 to support and develop the activities of its local customers in their respective sectors. In the field of Life Sciences, its offering is characterised by an in depth knowledge of the processes and methodologies associated with highly regulated environments. 

Assystem Belgium has ambitious growth objectives in the coming years. Having established ourselves with excellent references in the French speaking part of Belgium we are now looking to leverage our expertise across the entire country. To support this objective we are recruiting :

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