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Product Surveillance Associate

Ref: 15067940

Posted on 21 April 2022
Job Location
Boxmeer
Contract Type
Posting

Functieprofiel

Monitoring, trending and assurance of Product quality process performance, manage product quality systems (e.g. complaints, stability study management). Identifies product deviations/ trends, investigate deviations and escalate product issues.

Your activities would include:

  • set up general stability protocols
  • set up OGS (OnGoing Stability) year plan
  • ensure and review OGS year plan completion
  • write stability commitments and follow up (regulatory) commitments regarding stability testing
  • initiate and coordinate stability studies (including study management in SAP)
  • evaluate and manage changes of the stability program
  • evaluate and report stability results (e.g. for Product Quality Review)
  • evaluate stability profiles and perform trend analysis
  • assess stability impact of process changes, participate in Change Control teams
  • Access applicable registration requests (LOQ’s)
  • perform initial impact assessments and investigations concerning initial stability OOS (Out of Specifications) results
  • coordinate and document initial stability OOS investigation (including TrackWise)
  • perform yearly Product Quality Report assessment
  • set up Product Quality Report year plan
  • initiate and coordinate Product Quality Report data gathering at other departments
  • perform data trending and evaluate compile and review Product Quality Reports independently
  • prepare overall product assessment (for assessment board)
  • identify product and/or process improvements
  • responsible to maintain, perform and support the product quality complaint system
  • trend of product quality complaints
  • Escalate significant product quality complaints through the management notification process
  • Coordinate investigation requests from other MSD sites
  • Issue product quality complaint statements
  • Acts as Sub System Owner on system level and is a representative for the assigned Quality System
  • Supports as Sub System Owner inspections by authorities
  • is Top Level Procedure /Standard Operating Procedure /Work Instruction owner
  • Responsible for metrics/targets for site Quality, global Quality and Business Review meetings
  • Responsible for training on the assigned Quality system
  • Leads and/ or participates in improvement projects

Bedrijfsprofiel

Modis is part of the Adecco Group and is the Professional Staffing/Consulting group and we have Consultants in our team who we second to clients. Currently it employs 500 consultants in the Netherlands and 20,000 worldwide. The focus of Modis Life Sciences is mainly in the direction of QA, QC, PV, RA, R&D and process profiles within an organization in the field of Biotech, Pharmaceutical industry and Food. We have Consultants working at EMA, Janssen, Sanquin, Astellas, Unilever, Corbion, MSD, Aspen and many more!

We have an exciting new job opportunity as a Product Surveillance Associate at our pharmaceutical client at their location in Boxmeer.

Our client is a trusted global leader in veterinary medicine, dedicated to the health and well-being of animals. They offer the most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases.

Functie-eisen

You are perfect for the job when you have roughly the following profile:
  • A minimum of BaSc/BSc in a relevant field
  • Experience working within a GMP environment
  • Preferably several years of experience within farmaceutical QA/QC
  • Strong social skills

Do you have a question for us? Or are you looking for more information? Please let us know. 

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