Jobs

Principal QC & Stability Associate

Discipline
Engineering
Sector
Life Science
Location
Belgium
Vacancy ID
48006

Responsibilities

  • As a Principal QC & Stability Associate you are responsible for supporting release and stability of drug substance, drug products and diluent testing.
  • You coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
  • You coordinate and manage qualified materials program. You coordinate/lead multiple site/global projects and represent QC across organizations.
  • You contribute to the operation of Stability and Quality release testing programs across a multi product portfolio, managing timelines to meet corporate goals.
  • You execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment.
  • You generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
  • You originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product. 
  • You contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA. And you contribute to stability and quality sections of Annual Product Review. 
  • You collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports. 
  • You complete sample submission forms, track sample testing status, enter results into LIMS and compile and generate stability data tables and reports for commercial and clinical products for annual product reviews. 
  • You coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites.
  • You provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites. 
  • You contribute to maintenance of a list of approved test sites per product, methods performed/site, regulatory approvals per testing site. 
  • You maintain department and project metrics. 
  • You support the client oversight of procedure and document changes at CLOs.
  • You participate in routine internal and external Operations Meetings.

Requirements

  • Bachelor or master in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical/biotechnology industry. 
  • Experience in analytical GMP methods of biologics/antibodies (release and stability of drug substance, drug products and diluent testing), both compendial and non-compendial methods.
  • Experience in investigations, deviations, change controls, CAPAs, method improvements and gap assessments. 
  • Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers).
  • In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment. 
  • Good communication skills in English and Dutch. 
  • Analytical and quality mind-set, organized, communicative, flexible, eager to learn and enthusiastic. 

Let us handle the details

We at STAR are happy to take care of the details

01 // Education and development

Standing still in this fast-changing market is not an option. That's why you can combine this position at STAR with courses to further your specialist knowledge and skills. It's the best of all worlds: work, learn and be part of a challenging project all at the same time. Whether you need a springboard to launch your career or simply want to update your expertise, the training programmes offered by our STAR Academy ensure that your qualifications are always in line with your ambitions.

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