Quality Control Project Manager (M/F) Lisboa

Quality Control Project Manager (M/F)
Lisboa
Lisboa, Lisboa, Portugal

Quality Control Project Manager (M/F) Lisbon

Gen
Ibet 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, planning and designing 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 are looking for people who have:

• Ph
  D/MSc in Biotechnology, Chemical/Biochemical Engineering, Pharmaceutical Sciences, Biochemistry or related sciences;
• Minimum 2-3 years of work experience in the biotechnology field with previous experience in biochemical assays, cell 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
  - 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:

• Manage the Quality Control (QC) program on different projects;
• Ensure the QC Program for each project is in compliance with the guidelines/requirements;
• Coordinate with subcontractors the testing plans and deadlines for execution;
• Approve subcontractors' test method/study plans for the QC analysis of the different products;
• Review reports/Co
  As for completeness and confirm that test results are within product specifications;
• Report any recommended changes in procedures/study plans and follow up to ensure compliance;
• Coordinate the stability programs with subcontractors;
• Monitor the activities of subcontractors for Quality compliance;
• Prepare method of analysis, specifications, and Certificates of Analysis for the different projects/products.