Deviation Writer F/m/x

Who are we? : Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 6000 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

Brief Call : Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study : Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

We look forward to meeting you! Job description : As a Deviation Writer (F/M/X), you will be responsible of deviation management in production area and responsible to investigate the issues found out during the manufacturing process of customer.

Your main responsibilities will include:

• Management of deviations related to the activity in the manufacturing building or business unit.
• 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, gemba) / Investigate Issues in the manufacturing area.
• Investigate deviation 's impact on product
• Propose and create adequate CAPAs together with customer stakeholders.
• Complete the deviation in SAP system and collect appendixes.
• Guarant of the deviation closure within delay (including also intermediate milestones such as First review, Intermediate reports etc.).
• Escalate the deviations when needed (Deviation Review Board, CAPA Review Board ...)

THE IDEAL PROFILE

• You have a Bachelor / Master’s degree pharmacy, chemistry, biology, or a relevant domain.
• You have a good knowledge of deviation management system.
• You have a good knowledge of GMP regulations.
• You have notions/a prior experience on pharmaceutical production process / aseptic process.
• You have good communication skills; you are autonomous and rigorous.
• You speak fluently French. English or Dutch is a plus.

WE OFFER

We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential.

You will have access to:

• An international learning environment where you can challenge your knowledge with your colleagues
• Extensive trainings, both on technical matters and on soft skills
• The opportunity to bring new ideas to develop a thriving company
• Individual coaching and mentoring as well as the opportunity to learn from experts, which will support your growth as a professional and as a person.
• An attractive, tailor-made & evolutive career path.