Csv Consultant

2 weeks ago

Singapore amaris Full time
Job description
About the job


As a CSV Engineer, you will be responsible for preparing and executing test documentation for GMP computerized systems, as well as providing support in the troubleshooting of issues during the test execution.

You should have an excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.

To succeed in this role, you will be typically responsible for the following:

Plan and coordinate computer software validation projects and activities
Provide regulatory compliance, guidance, and support on CSV activities
Create, review, and approve system validation deliverables, such as validation plan
Participate in projects on setting up quality management system and quality risk management
Create and modify validation documentation including but not limited to the following:
Criticality assessments
CSV protocols (SAT, IQ, OQ) which verify if the system is compliant to regulatory and client requirements
Reports which summarize the result of the protocol execution
Support in the review and interpretation of data for accuracy in completed validations
Contribute to status reporting
Review executed protocols and generated reports in accordance with GMP and document quality requirements
Assist in troubleshooting issues identified by test performers during protocol execution
About you


We are seeking professionals with an entrepreneurial spirit, and ambitious self-starters who embrace challenges, to join our talented team at Amaris.

Bachelor's degree in Pharmaceutical Science, Life Science, Biology, biotechnology chemistry, chemical engineering, engineering, or a related discipline
Experience in computer system validation for qualifying Electronic Batch Management systems
Validation experience in reviewing and approving computer system validation lifecycle documentations, e.g., IQ, OQ, PQ protocols and reports
Hands-on experience in performing equipment validation
Strong written and verbal communication skills

Others:

4+ years of experience in Pharma/Life Sciences would be preferred
Interested in working in a multinational & demanding environment where excellence is the main driver
Keen sense of communication, strength of conviction, leadership, ability to identify talent and adapt to the local economy

Equal opportunity

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 6000 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.

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 - 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.

We look forward to meeting you

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