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 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
Mission Description: We are seeking three experienced Qualification Specialists to join our team. In this role, you will be responsible for supporting various qualification projects on-site. You will work with a range of equipment and systems, including but not limited to freezers, laboratory equipment, clean utilities (water and gas), visual inspection lines (packaging), metrology equipment, and classified areas.
Key Responsibilities:
- Write, review, execute, and approve technical documents such as Risk Assessments, User Requirement Specifications (URS), Design Qualifications (DQ), and Functional Design Specifications (FDS).
- Develop, review, execute, and approve validation protocols and reports, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Engage in continuous improvement initiatives based on technological advancements, regulatory changes, and company needs.
- Write, review, and approve Standard Operating Procedures (SOPs) and documents related to qualification activities.
- Manage Corrective and Preventive Actions (CAPA), Deviations, 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.
Skills and Knowledge Required:
- Minimum of 4 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.
- 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 (both internal and external).
- Ability to meet deadlines, report on activities, and proactively manage and resolve common issues related to the role.
- Proactive, autonomous, honest, and a team player.
- Fluency in French and English is mandatory.
Why Join Us? This is an exciting opportunity to work with a leading company in the pharmaceutical industry, where you will play a crucial role in ensuring the quality and compliance of our operations. If you are a motivated professional looking to make a significant impact, we encourage you to apply.
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.