principal qc stability associate.

• PHD with experience within Pharma industry
• Experience in physico-chemical analysis and/or potency testing of proteins
• Experience with GMP guidelines and a GMP working environment
• Knowledge of ICH and Pharmacopeia
• In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment
• Behavior competences: It is important that the person has an analytical and quality mind-set, is organized, communicative, flexible, eager to learn and enthusiastic.
• Basic qualification: BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry.
• Quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers).

Experience in:

• GMP
• Analytical GMP methods of biologics/antibodies (release and stability of drug substance, drug products and diluent testing), both compendial and non-compendial methods.
• Investigations, Deviations, change controls, CAPAs, method improvements and gap assessments.
• Familiar with regulations (EMA/FDA/…)

Within the SCES team of the client we're looking for a Principal QC & Stability Associate. The location could be both in Gent or in Geel , but the role itself can also be done remotely.

• Responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.
• Coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
• Coordinate and manage qualified materials program. Coordinate/Lead multiple site/global projects and represent QC across organizations.
• Contribute to the operation of Stability and Quality release testing programs across a multi[1]product portfolio, managing timelines to meet corporate goals.
• Execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)
• Generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
• Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product
• Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA; Contribute to stability and quality sections of Annual Product Review
• 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
• Complete sample submission forms; Track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews
• Coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable
• Provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites
• Contribute to maintenance of a list of approved test sites per product, methods performed/site, regulatory approvals per testing site
• Maintain department and project metrics, as appropriate.
• Support client oversight of procedure and document changes at CLOs.
• Participate in routine internal and external Operations Meetings

Are you interested in this vacancy? Then send your CV and cover letter to sam.goetschalckx@professionals.randstad.be or call +32 2 472 73 61

As an answer to your high performance & flexibility, Randstad Professionals offers you an competitive salary package, with some interesting extras like:

• Meal vouchers of €7
• Net representation cost of €80
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings

And on top of this you'll improve your skills and become an even bigger expert!