Amaris Consulting

Valdiation and Cleaning Expert Pharmaceuticals [F/M/X]

Posted: just now

Job Description

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 DescriptionJob descriptionAs part of our Life Sciences division, you will support our pharmaceutical partners in equipment qualification, process validation, and cleaning validation activities. Your expertise will ensure that products and processes comply with Good Manufacturing Practices (GMP) and regulatory standards.You will play a key role in guaranteeing the quality, reliability, and compliance of critical systems within highly regulated environments.Your missionsLead and execute equipment qualification (IQ/OQ/PQ) and cleaning validation activities. Develop and review validation protocols, reports, and risk assessments. Ensure alignment with GMP, regulatory guidelines (FDA, EMA), and internal procedures. Manage deviations, CAPAs, and change control related to validation activities. Participate in process validation and verification of manufacturing systems. Collaborate with quality assurance, production, and engineering teams to ensure project compliance. Provide technical support and mentoring to junior team members. Contribute to continuous improvement initiatives in qualification and validation strategy. Your profileDegree in Pharmacy, Chemical Engineering, Biotechnology, or related field. At least 4 years of experience in qualification, validation, or cleaning validation in the pharmaceutical industry. Strong understanding of GMP, Annex 15, and relevant international regulations. Proven ability to manage validation documentation and execution independently. Excellent analytical and problem-solving skills with attention to detail. Ability to work in cross-functional and multicultural teams. Fluent in English; additional languages are a plus. What We OfferA multicultural and dynamic environment that values initiative and innovation. Opportunities for career growth through the Amaris Academy and mentorship programs. The chance to work on international and high-impact projects in the pharmaceutical and life sciences sector. A collaborative structure where you are supported by experienced managers and experts. At Amaris, we believe in equal opportunities for all. We celebrate diversity and are committed to creating an inclusive environment where everyone can thrive, regardless of gender, age, origin, or background.

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