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Project Manager in Validation
il y a 4 semaines
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 youJob description
Looking for a Project Manager in Validation
Job description
Join our team and start a new adventure in an international and dynamic environment where you will be able to fulfill your career expectations in a fast-growing organization.
As a key member of our team, you will be responsible for managing and coordinating validation projects, ensuring compliance with international quality standards, and driving process improvement initiatives.
Your missions
- Oversee project management activities related to validation in equipment and process changes.
- Lead eCC (electronic Change Control) management and validation activities.
- Coordinate and validate changes in equipment and processes, including freeze dryers, autoclaves, isolators, CIP/SIP, Mediabulk, utilities (EDI, EPI, EUF, VP, ACP, N2), and process control automation equipment.
- Define and implement an adequate validation strategy in compliance with FDA, EMEA, and international quality standards.
- Ensure and coordinate support for validation projects, including planning, weekly validation activities, resource management, and cost control.
- Review and approve protocols, reports, checklists, and risk assessments related to validation.
- Manage deviations, out-of-specifications, and CAPAs, bringing expertise to investigations and issue resolution.
- Oversee documentation, including SOPs, operational forms, and master data required for projects.
Preferred qualifications:
- Advanced validation expertise.
- Strong experience in change management.
- Proficiency in eCC processes.
- P&P or similar experience/expertise.
What we offer
- An international, collaborative working environment.
- Opportunities for continuous learning and professional growth.
- A robust internal training system to develop your expertise.
- A workplace that fosters innovation and teamwork.
Diversity & Inclusion:
We are committed to creating a diverse and inclusive workplace. We welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
