Job description
Amaris will be prioritizing applicants who are currently based in Singapore.
Key Responsibilities:
Validation Planning: Develop and implement CSV strategy and validation plans for computerized systems, including Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Electronic Batch Records (eBR), and other relevant software.
Validation Documentation: Create and review validation documentation, including validation protocols, test scripts, and traceability matrices.
Testing and Execution: Execute validation protocols and test scripts, documenting test results, deviations, and issues. Perform functional testing, security testing, and data integrity checks.
Change Control and Documentation: Implement and manage change control processes for computerized systems, including assessing the impact of changes on validated systems.
Data Integrity: Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
Qualifications:
Bachelor's degree in computer science, engineering, pharmaceutical sciences, or a related field.
Strong knowledge of pharmaceutical regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and quality standards (GMP, GLP).
Experience in computer systems validation within the pharmaceutical industry.
Proficiency in validation tools, methodologies, and validation testing techniques.
Familiarity with software development life cycle (SDLC) processes and methodologies.
Excellent project management skills and attention to detail.
Effective communication and collaboration skills.
Knowledge of data integrity principles and security best practices.
Experience with regulatory audits and inspections is a plus.
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!
