Job description
Amaris will be prioritizing applicants who are currently based in Singapore.
Key Responsibilities:
Develop and execute system qualification protocols for QC systems, including computerized systems, analytical instruments, and control systems.
Ensure compliance with regulatory requirements and industry standards for system qualification.
Collaborate with cross-functional teams to define system requirements and specifications.
Perform risk assessments and impact analyses related to system qualification activities.
Troubleshoot and resolve system qualification issues to ensure reliable and compliant operations.
Maintain documentation and records related to system qualification processes.
Participate in validation activities and support validation engineers in related tasks.
Contribute to continuous improvement initiatives for system qualification processes.
Qualifications and Skills:
Bachelor's degree in engineering, computer science, or a related field.
Experience in system qualification within the pharmaceutical or biotech industry.
Knowledge of regulatory requirements such as FDA, cGMP, and ICH guidelines related to computerized systems validation.
Familiarity with validation principles and practices for analytical instruments and control systems.
Strong understanding of risk assessment methodologies and validation documentation requirements.
Excellent communication and collaboration skills.
Ability to work effectively in a cross-functional team environment.
Detail-oriented with strong analytical and problem-solving abilities.
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. Were 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!
