Quality System Specialist - Singapore - amaris

amaris

Verified Company

Singapore

3 weeks ago

Posted by:

Wei Jie

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Description

Job description
About the job
Monitor the QMS for compliance with procedures, and completion of deliverables according to committed timelines.
Prepare reporting information for Change Control Review Board and Investigation Review Board.
Identify, investigate, and resolve complex technical issues using problem-solving skills. Notifies management of actions taken.
Analyze and interpret projects, studies, or investigations to determine next steps. Make decisions and notify management of action taken.
Write new documents and revise existing documents, independently.
Perform QA review/approval of controlled documents.
Provide support to site personnel performing Deviation Investigations, CAPAs, and Change Controls.
Receive overall project direction from management but complete most work independently.
Participate in internal or supplier audits.
Develop and provide training on department-specific procedures and systems.
Participate in required training and keep training files current.
Identify, propose, and implement Quality Process and system improvements.
Complete mandatory training within the required timeframe.
About you
Bachelor's degree in Chemistry, Chemical Engineering Science or related technological field.
4-6+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry.
Experience in manufacturing equipment, computer system validation and Quality Management Systems.
Experience to Reviews, Approve validation lifecycle documentation, e.g. IQ, OQ, PQ protocols and reports.
Hands-on experience in performing equipment validation, computer system validation.
Knowledge in 21CFR Part 11 and GAMP5.

Experience in coordinating and managing cross-functional for the post-execution review, discrepancy management, status reporting and post-execution approval of all validation documents, SOPs, change control.

Review and Approve routine SOP, FORMs and any relevant procedures that is impacted by QC LIMS and MODA systems.
Experience to Reviews, Approve computer system validation lifecycle documentation, e.g. risk assessments, technical specifications.
Knowledge in recombinant processes under GMP environment.
Knowledge in Process Control Systems, preferred Siemens PCS7 platform.
Able to logically solve problems in order to find timely solutions.

Language:
Excellent command of English.

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