Lab Equipment Qualification - Singapore - amaris

amaris

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

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Description

Job description
About the job
Development validation protocols from Validation Plans.
Perform lab equipment including computerized systems validations, revalidations, requalifications, and on-site projects.

Perform Lab Equipment Validation Maintenance Review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.

Support with decommissioning of the lab equipment.
Perform investigations to the discrepancies during validation and qualification / re-qualifications, if any.

Participate in the coordination of efforts of multi-disciplined project team on the writing, performance, documentation and approvals of validation lifecycle documentations.

Participate in review of Vendor Validation Protocols / Reports including discrepancies investigation / closure
Ensure approval of validation documentation on a timely basis.
Ensure protocols are executed as intended according to the study plan/approach.
Assure high scientific quality of all studies and that they are carried out in a safe manner.

About you
A minimum of 3 years' experience in Pharmaceutical manufacturing and cGMP environment. In depth knowledge of cGMPs and validation.
Familiarity with Regulatory requirements and local Codes & Standards (e.g.
FDA, EMEA,GAMP and ICHQ7)
Significant experience within the biotech industry, preferably directly with Lab Equipment Qualification (LEQ) experience.
Experience in a GMP facility, with strong knowledge of GMP regulations.
Hands on working experience on Validation and QA experience is preferred.
Working experience with validation procedures.
Must be able to effectively multi-task and work independently, project management skills highly desired.
Strong communication skills and self-motivated.

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