Quality & Validation Engineer (W/M/X)
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
We are currently seeking a Quality and Validation Engineer to join our Quality team to ensure GMP standards are met within our operations. As a Quality and Validation Engineer, you will play a key role in ensuring the quality of information reported in our systems and documentation, in accordance with current guidelines, compliance, and regulatory requirements.
?? Your Responsibilities:
- Review deviations within engineering events in quality systems to verify their acceptability and compliance with standard procedures and regulatory requirements. This includes conducting or approving relevant investigations, impact assessments (concerning the impact on equipment/product/material), and defining appropriate CAPA.
- Review and approve engineering-controlled documentation being revised.
- Review and approve requalification of cleaning in place/sterilization in place/temperature control units, as well as associated protocol deviations.
- Perform change control assessments from a Quality Engineering standpoint.
- Attend all relevant meetings to perform the above-mentioned tasks.
- Adhere to the escalation process.
- Ensure the completion of relevant training and software access management in accordance with current policies.
- Occasionally perform other tasks related to conventional quality oversight to support the team (e.g., continuous improvement initiatives, GMP tours of technical areas, etc.).
?? Your Profile:
- Technical and scientific academic background.
- Minimum of 2 years of operational experience in cGMP within a Quality Ops or Engineering department at a manufacturing site in the pharmaceutical, biotechnology, and/or sterile injectable products industry.
- Knowledge of quality standards (cGMP) and quality systems (deviations, CAPA, change control, training, documentation, etc.).
- Technical knowledge in maintenance, facilities/utilities, HVAC, and calibration is a plus.
- Proficiency in both French and English.
?? Our Corporate Culture:
- Agility: Thrive in a flexible, dynamic, and stimulating environment.
- International: Benefit from international collaborations and numerous mobility opportunities.
- Intrapreneurship: Get involved in side initiatives or develop your own business unit.
- Supportive Management: Receive personalized support throughout your professional journey.
Amaris Consulting is committed to diversity and inclusion. We encourage applications from all qualified individuals, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.
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