Process Validation For Biological Safety

The Company:

The company is an innovative French company of 30 people specializing in the design and manufacture of orthopedic Medical Devices for extremity surgery. The expectations regarding practitioners performance are constantly increasing regulatory requirements are rising and the optimization of technical platforms is a necessity. In this changing environment their mission is to provide simple and innovative solutions to simplify surgical procedures and equipment management in the operating room and to ensure the efficiency of surgical teams. They provide healthcare professionals with innovative solutions not only in product design but also in the use of new materials.

Main Mission:

Reporting to the Quality Regulatory and Clinical Management you are responsible for:

• Leading actions related to the validation of processes known as biological safety including device cleaning packaging sterilization and transportation
• Leading biocompatibility studies of their products.

In this role you will be required to:

• Develop Master Validation Plans (MVP) and update them as necessary
• Define write/verify process validation protocols
• Organize the conduct of planned analysis tests and follow up with analysis laboratories
• Implement statistical techniques necessary for data analysis
• Write/verify process validation reports
• Manage any nonconformity deviation CAPA files associated with validation activities
• Participate in the management of suppliers involved in biological safety processes particularly by drafting subcontractor specifications conducting audits as a technical expert
• Evaluate the impact of change files on validation files
• Define validation strategies for ongoing development projects
• Participate in process FMEAs
• Develop biocompatibility study strategies for their products and organize test execution with laboratories.

Your Profile:

• With a Bachelors degree in Engineering Pharmacy or equivalent
• You have 35 years of professional experience in a similar position imperative in the Medical Devices or Pharmaceutical industry.
• Required Quality/Competencies
• Ability to engage in your professional activity
• Good writing skills in English
• Good knowledge of statistical methods applied to process validation.
• Indepth knowledge of regulations and standards associated with process validation (ISOCFR 820 ISO19227 ISO116071 and 2 ASTM D4169 ISO 111371 to 3 ISO 117371 and 2).
• You have perfect command of computer tools (Word Excel PowerPoint).

Remote Work :

No