GenIbet is a GMP biopharmaceutical CDMO (Contract Development Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and GMP manufacturing services to research groups, biotech and pharma companies.

  

Quality Control Project Manager (M/F)

Lisbon/Oeiras

 

This person will integrate the QC department, that plan and design the testing scheme of innovative biopharmaceuticals, being the main contact point for the outsourced Quality Control testing inside the company for some of the projects, in close collaboration with the project management department for the success of the projects.

 

We´re looking for people who have:

 

  • PhD/MSc in Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biochemistry or related sciences;
  • Minimum 2 -3 years of work experience in biotechnology field with previous experience in biochemical assays, cells’ manipulation or molecular biology;
  • Background in Biological processes and Products Characterization (is a plus);
  • Knowledge in Good Manufacturing Practices (is a plus);
  • Strong organizational skills and motivation to work within cross-functional teams;
  • Flexibility and willingness to work with diverse areas and technologies;
  • Analytical skills and ability to make decisions under pressure;
  • Good team spirit;
  • Proficiency in spoken and written English.

 

Technical/Functional Responsibilities:

  • Manages the Quality Control (QC) program on different projects;
  • Ensures the QC Program for each project is in compliance with the guidelines/requirements;
  • Coordinates with subcontractors the testing plans and deadlines for execution;
  • Approves subcontractors test method/study plans for the QC analysis of the different products;
  • Reviews reports/CoAs for completeness and confirms that test results are within product specification;
  • Reports any recommended changes in procedures/study plans and follows up to ensure compliance;
  • Coordinates the stability programs with subcontractors;
  • Monitors the activities of subcontractors for Quality compliance;
  • Prepares method of analysis, specifications and Certificates of analysis for the different projects/products.

 

 

Please send your CV to: [email protected]

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