Production and Quality Specialist
1 week ago
This position supports supplier management initiatives, encompassing quality activities such as supplier qualification, periodic performance evaluation, and decommissioning.
We are seeking a candidate with experience in production and/or quality control to perform the following responsibilities:
- Liaise with stakeholders (manufacturing team, procurement team, QC etc.) and suppliers (manufacturers and distributors of supplies, outsourced service providers etc.) to ensure supplier questionnaires are completed with relevant documents.
- Liaise with affiliate sites personnel for qualified supplier information deck to assess on the leverage of supplier qualification documents.
- Lead/Support on-site audit at supplier site (if necessary). Prepare audit agenda, audit report, and coordinate with supplier for CAPA response to close of audit observations.
- Draft Quality Agreement (QAA) with new suppliers or review existing QAA for existing suppliers engaged by affiliate sites
- Perform quality assessment based on company procedures to determine if suppliers can be qualified for GMP use.
- Update qualified supplier list.
- Perform periodic performance monitoring, supplier change notification, and decommissioning of supplier.
About You:
- Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in supplier qualification QA.
- Familiarity with FDA, EMEA, HSA, and PIC/S GMP requirements.
- Experience in leading audits is preferred.
- Proficient in English listening, speaking, reading, and writing.
- Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise, and other software applications.
Please note that we are looking for candidates who possess the following qualities:
- Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
- At least 8 years of working experience in production and/or quality management, with a minimum of 5 years in supplier qualification QA.
- Familiarity with FDA, EMEA, HSA, and PIC/S GMP requirements.
- Experience in leading audits is preferred.
- Proficient in English listening, speaking, reading, and writing.
- Skilled in Microsoft Word, Excel, PowerPoint, SAP, TrackWise, and other software applications.
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