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 7,600 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.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
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.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
Job description
Type of Mission:
As a Qualification-Validation Specialist for equipments, you will be involved in various qualification projects during the shutdown period at our facility. Your expertise will be crucial in ensuring the qualification of a range of equipment and systems, including but not limited to:
Freezers and refrigerators
Laboratory equipment
Clean utilities (water and gases)
Classified areas
Profile: Qualification Specialist
Skills and Knowledge Required:
Minimum of 5 years of confirmed experience in Equipment Qualification/Validation.
Mastery of activities related to the V-cycle.
Knowledge of additional qualification methods (e.g., C&Q, ASTM E2500) is a plus.
Experience with clean utilities (Water for Injection, Purified Water, Clean Steam) is advantageous.
Proven experience in writing, executing, and reviewing qualification protocols and reports, as well as technical documents.
Experience in conducting Risk Analysis (e.g., FMEA).
Proficient in Root Cause Investigation techniques (e.g., Fishbone/Ishikawa/6M, 5 Whys).
Experience working in a GMP environment.
Strong understanding of regulatory requirements related to qualification/validation (particularly EU GMP, 21 CFR).
Customer-oriented mindset (internal and external).
Ability to meet deadlines, provide activity reporting, and proactively manage and resolve common issues related to the role.
Traits of proactivity, autonomy, honesty, integrity, and being a team player.
Proficiency in French and English is mandatory.
Responsibilities & Tasks:
Write, review, execute, and approve technical documents such as Risk Assessments, URS, DQ, FDS (non-exhaustive list).
Write, review, execute, and approve validation protocols and reports (FAT/SAT, IQ, OQ, PQ).
Drive continuous improvement based on technology, regulations, and/or company needs.
Write, review, and approve SOPs and documents related to qualification activities.
Manage CAPA, Deviation, Change Control, and other quality systems related to qualification activities.
Provide support during customer and regulatory audits.
Deliver reliable support to internal and external clients to ensure timely completion of activities/projects while maintaining a satisfactory quality level.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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