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Lab Instrument Qualification Consultant

3 weeks ago


Singapore PQE Group Full time

3 days ago Be among the first 25 applicants
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Are you ready to join a
world leader
in the exciting and dynamic fields of the
Pharmaceutical and Medical Device industries ?
PQE Group
has been at the forefront of these industries
since 1998 , with
40 subsidiaries
and more than
2000 employees in Europe, Asia and the Americas .
Due to our constant growth, we are looking for a
Lab Instrument Qualification Consultant
to support a strategic qualification project in a GMP-regulated laboratory located in
Singapore.
You will be responsible for:
Managing the entire qualification workflow of analytical instruments in a GMP-regulated laboratory environment. The instruments include: Cell Counter, PRS3 Microplate Readers, M5e Microplate Readers.
Drafting Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols using client-specific templates and aligning them with vendor-provided documentation.
Witnessing the execution of IQ/OQ activities performed by equipment vendors, verifying correct test implementation and collecting evidence to ensure traceability and compliance.
Performing Performance Qualification (PQ) testing directly on-site in collaboration with the client's laboratory personnel, including instrument operation and preparation of standards, reagents, and samples.
Preparing and finalizing IQ/OQ/PQ qualification reports, and supporting the drafting and completion of Standard Operating Procedures (SOPs) in alignment with GMP standards and the client's documentation system.
Collaborating with stakeholders including vendors, QA, and client teams to ensure project alignment, on-time delivery, and compliance with regulatory requirements.
Ensuring all documentation adheres to Data Integrity principles (ALCOA+), GAMP5 guidelines, and current GMP regulations.
About You
5–7 years of experience in laboratory instrument qualification in GMP-regulated environments
Solid knowledge of the full qualification lifecycle (IQ/OQ/PQ)
Fluent in English (written and spoken)
Mandarin Chinese is a nice-to-have
Strong communication and interpersonal skills
Ability to work collaboratively with cross-functional teams and vendors
Detail-oriented, organized, and able to manage tasks under tight deadlines
Quality-driven mindset with a strong sense of ownership and accountability
First Project you will be assigned to:
Availability : Full on-site
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.
If there's a positive match, a technical interview with the Hiring Manager will be arranged.
In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.
Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of the PQE team, you will be part of a
challenging, multicultural company that values collaboration and innovation . PQE Group gives you the
opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.
If you are looking for a
rewarding and exciting career , PQE Group is the perfect place for you.
Apply now and take the first step towards an amazing future with us.
Seniority level
Seniority level Mid-Senior level
Employment type
Employment type Full-time
Job function
Job function Project Management, Consulting, and Quality Assurance
Industries Pharmaceutical Manufacturing and Business Consulting and Services
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