QC Stability Associate

Do you have experience in validation within the pharma industry? Keep on reading! Our client based in Geel is looking for a QC stability associate. Geel is too far? No problem! This position is 100 % remote working.

Interested? Send your CV and motivation letter to soraya.benaissaoui@professionals.randstad.be or call me on 02 2 472 94 70

• 
  Analytical background
• Experience in Validation of Analytical methods
• Experience with Technology Transfers is a plus
• 4 - 5 years experience within QC (labo practical or method)
• Statistical background is a plus to understand the proces
• Knowledge ENG
• Immediately available for a Fulltime or 4/5

The person needs to pick up the PC in Geel, furthermore the person can choose from which site they work (Ghent, Diegem, Brussels or Geel) or work remotely.

Next to an attractive salary we offer you:

• 
  Meal vouchers of 7
• Net representation cost of 50
• Hospitalization insurance
• Home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers

On top you have the ablility to follow various trainings and improve your skills to become even a bigger expert!

Are you interested in this position? Apply at soraya.benaissaoui@professionals.randstad.be or call me on +32 2 472 94 70

As an organization, we are constantly moving and growing and we make sure our people grow with us. You’ll have the chance to create your own opportunities and the freedom to make them happen, including working in different parts of the world and experiencing new cultures. Our flexible working environment had helped us build a dynamic and inclusive workplace that operates on trust and respect and allows you to live the life you want to live.

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  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.
• Contribute to the operation of Stability and Quality release testing programs across a multiproduct 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