Job Specifications
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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
As an Analytical Development Specialist, you will play a pivotal role in ensuring the quality and compliance of analytical methods within a GMP-regulated environment. You will work directly within the client’s Quality Control (QC) laboratory, contributing to method development, validation, and continuous improvement initiatives in alignment with international standards.
Your key responsibilities will include:
Method Development & Validation: Lead the development, optimization, and validation/verification of analytical methods in the QC lab, applying Analytical Quality by Design (AQbD) principles and adhering to ICH Q2(R1) and Q14 guidelines.
GMP Documentation: Author, review, and approve critical quality documents such as validation protocols/reports, risk assessments (e.g., FMEA), periodic reviews, and technical transfer reports in compliance with Ph. Eur., USP, and internal procedures.
Quality Lab Support: Provide expert support during quality investigations (OOS, deviations, CAPAs), contributing to root cause analysis and scientifically sound corrective actions.
Continuous Improvement: Drive process enhancements in analytical operations, promote cross-functional collaboration, and support digital or lean initiatives to improve lab efficiency and data integrity.
Regulatory Readiness: Ensure analytical practices are audit-ready and aligned with global regulatory expectations.
Profile Requirements
Education & Experience:
Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
Minimum of 3 years of hands-on experience in a GMP-compliant environment within the pharmaceutical or biotech industry.
Technical Skills:
Proven expertise in endotoxin testing (LAL), bioburden, and microbial testing; experience with other analytical techniques (HPLC, GC, spectrophotometry) is a plus.
In-depth knowledge of pharmacopoeial methods (Ph. Eur., USP) and method verification/validation requirements.
Demonstrated experience in analytical method development and validation using AQbD approaches and ICH guidelines.
Familiarity with quality systems: deviations, CAPA, change control, and risk management (e.g., ICH Q9).
Soft Skills & Attributes:
Strong project management skills and a proactive, results-driven mindset.
Ability to work under pressure and manage multiple priorities in a dynamic environment.
Excellent communication and interpersonal skills – you are a collaborative team player who can engage effectively with scientists, QA teams, and management.
Fluent in English (written and spoken); proficiency in French or Dutch is a big plus.
Why Join Amaris?
Be part of high-impact projects with leading players in the Life Sciences industry.
Access to continuous learning, certifications, and professional developme