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
Position Overview: As a Quality Assurance Validation Specialist, you will play a crucial role in ensuring that our products meet the highest quality standards and comply with all regulatory requirements. You will be responsible for validating processes, equipment, and systems to ensure they operate effectively and consistently.
Key Responsibilities:
Develop, execute, and maintain validation protocols and reports for equipment, processes, and systems.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements and internal quality standards.
Conduct risk assessments and impact analyses to identify validation needs.
Review and approve validation documentation, including IQ, OQ, and PQ protocols.
Provide training and support to staff on validation processes and best practices.
Participate in internal and external audits and inspections.
Continuously improve validation processes and methodologies.
Qualifications:
Bachelor’s degree in Life Sciences, Engineering, or a related field.
Minimum of [X] years of experience in QA validation within the pharmaceutical or biotechnology industry.
Strong knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards (GxP, ISO).
Excellent analytical and problem-solving skills.
Strong attention to detail and ability to work independently and as part of a team.
Proficient in validation documentation and quality management systems.
What We Offer:
Competitive salary and benefits package.
Opportunities for professional development and career advancement.
A collaborative and innovative work environment.
The chance to make a meaningful impact in the pharmaceutical industry.
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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