QA Consultant

2 weeks ago

Singapore PQE Group Full time

Overview
QA Consultant – Supplier Qualification & Audits to support projects in Singapore.
Responsibilities
Perform supplier qualification activities by liaising with stakeholders (manufacturing team, procurement team, QC, etc.) and suppliers (manufacturers, distributors of supplies, outsourced service providers, etc.) to ensure supplier questionnaires are completed with relevant documents (e.g., business license, ISO certificates).
Liaise with affiliate site personnel for the qualified supplier information deck to assess leverage of supplier qualification documents.
Lead or support on-site audits at supplier sites (as necessary). Prepare audit agenda, audit report, and coordinate with the supplier for CAPA responses to close audit observations.
Review and approve supplier questionnaires, quality agreements (QAA), and related documentation.
Perform quality assessment based on company procedures to determine if a supplier can be qualified for GMP use.
Assess supplier-related risks and ensure mitigation actions are defined and implemented.
Support incoming material qualification and supplier monitoring activities.
Participate in internal audits and support regulatory inspections regarding supplier compliance.
Manage supplier-related quality events, including deviations, CAPAs, and change controls.
About you
Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
At least 3 and max 8 years in supplier qualification QA
in pharmaceutical/biopharma industry
Familiarity with FDA, EMEA, HSA and PIC/S GMP requirements.
Experience in leading audits is preferred .
Experience with biopharma commercial quality systems is preferred.
Proficient in English listening, speaking, reading, and writing.
Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise, etc.
Strong learning ability.
Effective at cross-functional communication and collaboration.
First Project you will be assigned to
Availability : Full on-site
Type of Contract : 6 months
Next Steps
Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there is a positive match, a technical interview with the Hiring Manager will be arranged. If the outcome is positive from the Hiring Manager interview, the recruiter will contact you for further steps or to discuss our proposal. If the outcome is negative, we will contact you to halt the recruitment process.
Working at PQE Group
As a member of PQE Group, you will be part of a
challenging, multicultural company that values collaboration and innovation . PQE Group offers the opportunity to work on international projects, improve your skills, and interact with colleagues from around the world. If you are looking for a
rewarding and exciting career , PQE Group is the right place for you. Apply now and take the first step towards an amazing future with us.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Quality Assurance, Consulting, and Manufacturing
Industries
Business Consulting and Services
IT Services and IT Consulting
Johor Bahru, Johor, Malaysia — 1 month ago
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