Csv Consultant - Singapore - amaris

amaris

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

beBee Recruiter

Description

Job description
About the job
Plans and coordinates computer software validation projects and activities
Provides regulatory compliance, guidance and support on CSV activities
Creates, reviews and approves system validation deliverables, for example: validation plan
Participates in projects on setting up quality management system and quality risk management
Create and modify validation documentation including but not limited to:
Criticality assessments
CSV protocols (SAT, IQ, OQ) which verify if the system is compliant to regulatory and client requirements.
Reports which summarize the results of the protocol executions.
Exception reports which identify defects or issues during test 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 of issues identified by test performers during protocol execution.
About you
Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline
Experience in computer system validation in qualifying Electronic Batch Management systems
Experience to Reviews, Approve computer system validation lifecycle documentations, e.g. IQ, OQ, PQ protocols and reports
Experience in DCS/ PCS system
Hands on experience in performing equipment validation
Excellent communication skills (verbal and writing)

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