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!
ABOUT THE JOB
The Quality Operations Specialist plays a critical role in overseeing the quality system within manufacturing and production areas. This includes monitoring, documenting, and addressing quality-related issues to ensure compliance with company standards and regulatory requirements. The role involves collaborating with various teams to uphold the highest quality standards for released batches.
Key Responsibilities:
- Ensure manufactured products adhere to company policies, processes, and procedures.
- Provide quality oversight for GMP manufacturing, including technical operations, engineering, QC labs, and supply chain activities.
- Review and approve incoming material inspections, batch records, manufacturing logs, and line-clearance activities.
- Manage the release of materials and product batches.
- Investigate non-compliance issues in materials, QC testing, manufacturing, warehousing, and products.
- Support change management processes to ensure compliance with policies.
- Conduct routine inspections of manufacturing, engineering, warehouse, and QC areas to maintain compliance.
- Contribute to new product introductions, operational excellence initiatives, and other management-assigned tasks.
ABOUT YOU
- Bachelor’s degree in Natural Sciences (Biology, Chemistry), Pharmacy, or Engineering.
- 2+ years of experience in a pharmaceutical or biopharmaceutical quality/compliance environment (GxP).
- Familiarity with quality regulations and standards affecting APIs/Biologics.
- Experience with SAP and Trackwise is a plus.
- Strong knowledge of GxP requirements and regulatory standards.
- Ability to quickly understand products and processes to address quality issues effectively.
- Commitment to maintaining high-quality standards with integrity and a strong work ethic.
- Excellent planning, scheduling, and communication skills.
- Strong interpersonal skills for effective collaboration.
WHAT WE OFFER
- An international community bringing together diverse perspectives and expertise.
- Opportunities for continuous professional development through our robust training programs.
- A vibrant workplace with frequent internal events fostering collaboration and innovation.
- Commitment to Corporate Social Responsibility through our sustainability initiatives.
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.
