As the Infrastructure Compliance Manager you will lead and guarantee the respect of the Quality standards of internal MedinCell activities for equipment, rooms, utilities and processes regarding manufacturing, testing and distribution Quality needs.
We’re offering a fantastic opportunity as this is a newly created role and You will be working as part of an extensive international team and develop strong working relationships across the division and with our customers. You will work across a range of projects and will be able to develop your knowledge and experience. We are looking for someone who is highly organised and able to manage projects: someone who is proactive and driven in their style of working and who has exceptional communication and relationship building skills.
- Contributes to define needs in qualification of equipment, utilities, computerised systems, analytical methods and guarantee their compliance to GMP standards in use. Establishes validation master plan.
- Ensures compliance of the computerised systems with GMP, including their validation.
- Creates and improve the SOP related to GMP compliance of the operational building, including environmental monitoring and pest control.
- Creates and improve the SOP related to GMP compliance of equipment qualification and process validation, including cleaning.
- Approves qualification and validation protocols, qualification and validation reports for equipment, process development, manufacturing and testing.
- Is responsible for the correct preventative maintenance of all relevant equipment and takes care of the metrology for relevant equipments.
- Manages weekly meetings for qualification and validation quality eventsIdentifies the risks for GMP compliance of the operational building with equipment qualification and process validation and propose solutions in collaboration with the other departments/teams. Manages the corresponding risk assessments.
- Brings appropriate input on Quality management of internal MedinCell activities to the Quality Review
- Participates actively in Regulatory Authorities inspections, partners/customers audits (including preparation).
- Work closely with all the Quality members and participate if needed to the other Quality activities.
- PharmD or equivalent in pharmaceutical sciences with industrial pharmaceutical focus or engineer in quality.
- At least 5 years of pharmaceutical experience (pharma/biopharma industry) in Qualification/ Validation for Quality Assurance department.
- Knowledge of relevant GxP guidances and qualification/validation guidelines.
- Fluent level of English
- Experience in drug product development and clinical trials would be appreciated.