Job Description

Job description
About the job
Plans and coordinates computer software validation projects and activities.
Provides regulatory compliance, guidance and support on CSV activities.
Creates, reviews and approves system validation deliverables, for example: validation plan.
Participates in projects on setting up quality management system and quality risk management.
Create and modify validation documentation including but not limited to:
Criticality assessments
CSV protocols (SAT, IQ, OQ) which verify if the system is compliant with regulatory and client requirements.
Reports which summarize the results of the protocol executions.
Exception reports which identify defects or issues during test execution.
Support in the review and interpretation of data for accuracy in completed validations
Contribute to status reporting
Review executed protocols and generated reports in accordance with GMP and document quality requirements.
Assist in troubleshooting issues identified by test performers during protocol execution.
About you
Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline.
Experience in computer system validation in qualifying Electronic Batch Management systems.
Experience to Reviews, Approve computer system validation lifecycle documentations, e.g. IQ, OQ, PQ protocols and reports.
Hands on experience in performing equipment validation.
Excellent communication skills (verbal and writing).

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.

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 \xe2\x80\x93 this is made possible by an international team of 6000 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\xe2\x80\x99re 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!