Job description
Job Summary:
We are seeking a motivated and detail-oriented CGMP Engineer to join our client's team. The ideal candidate will have a strong understanding of Current Good Manufacturing Practices and will be responsible for ensuring compliance and quality within the manufacturing process. This role involves conducting root cause analysis, managing deviations, and implementing corrective and preventive actions.
Key Responsibilities:
- Conduct root cause analysis for deviations and ensure effective CAPA implementation.
- Manage change controls and assess their impact on processes and compliance.
- Collaborate with cross-functional teams to ensure CGMP compliance.
- Provide knowledge and training on root cause analysis and impact assessment.
- Document findings and maintain accurate records in accordance with regulatory requirements.
- Participate in training sessions to enhance skills and knowledge.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 1-3 years of experience in a CGMP environment (Junior/Medior level).
- Strong understanding of CGMP regulations and compliance.
- Excellent analytical and problem-solving skills.
- Proficient in Dutch and English (both written and spoken).
- Ability to work collaboratively in a team environment.
What We Offer:
- Opportunity to work with a leading client in the pharmaceutical industry.
- Comprehensive training.
- A dynamic and supportive work environment.
- Competitive salary and benefits package.
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 – this is made possible by an international team of 7500 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!