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Qualification validation specialist
1 week ago
Qualification Validation Specialist (Middle/Senior)
Permanent Job
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 youInterviews
: 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 opportunitiesCase 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 youJob description
ABOUT THE JOB
Provide quality oversight for validation, qualification, and replacement of manufacturing process equipment.
Assess and approve acceptance tests, reports, and documentation in line with policies and compliance requirements.
Review and authorize engineering changes, deviations, and exceptions during validation activities.
Work closely with multidisciplinary teams to plan, coordinate, and execute validation procedures efficiently.
Support technical modifications and undertake additional validation-related duties as assigned.
Maintain compliance with c GMP standards while ensuring adherence to site safety and security regulations.
Act as a liaison with Roche stakeholders to ensure proper implementation of validation processes.
Oversee work area maintenance, ensuring cleanliness and organization during and after validation tasks.
ABOUT YOU
At least 5 years of experience in equipment validation within a GMP-regulated environment.
A Bachelor’s degree in Engineering, Life Sciences, or a related field is preferred.
Strong knowledge of c GMP standards and regulatory compliance for equipment validation.
Experience in reviewing and approving validation protocols, deviations, and change requests.
Ability to lead and coordinate validation activities across multiple projects.
Excellent problem-solving skills and keen attention to detail.
Strong interpersonal and communication skills to work effectively with cross-functional teams.
WHY AMARIS?
At Amaris Consulting, we believe in creating a thriving, positive workplace where every team member can grow, connect, and make a real impact. Here’s what you can expect when you join our dynamic community:
Global Diversity
: Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.
Trust and Growth
: With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.
Continuous Learning
: Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.
Vibrant Culture
: Enjoy a workplace where energy, fun, and camaraderie come together through regular afterworks, team-building events, and more.
Meaningful Impact:
Join us in making a difference through our CSR initiatives, including the We Care Together program, and be part of something bigger.
EQUAL OPPORTUNITY
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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