Senior Validation Technician (Process, Cleaning and Transport)
FAMAR is a European provider of pharmaceutical manufacturing and development services (CDMO) with a legacy of 75 years of technology expertise.
Building on its experience, FAMAR is a reliable partner to deliver flexible solutions, from development to production and distribution. Continuity and customer care are the cornerstones of FAMAR’s long-term business-oriented partnership.
Through the commitment of 1800 employees worldwide, and with a network of 6 production sites in Europe, FAMAR supplies a wide range of more than 1800 products in a variety of dosage forms, in 80 international markets.
Mission
* Follow the General Validation Plan and the validation planning established for the Plant.
* Undertake process, cleaning and transportation validations in accordance with the NCF and the Group's Quality Directives.
* Prepare validation protocols and reports, as well as the necessary documentation to develop the Plant validation program.
* Guarantee the achievement of validations in accordance with the NCF and the Group's Quality Directives.
* Plan for each element to validate the resources, necessary actions, responsibilities and documentation to be generated for its achievement.
* Contact the departments involved, for the correct development of the process validation, cleaning or transportation.
* Prepare process validation, cleaning or transportation protocols for each element to be validated.
* Prepare reports with the validation results.
* Write, supervise and keep updated the procedures linked to your activity and ensure their application.
* Periodically prepare reports on your area of competence.
* Evaluate and manage change control requests in your area of responsibility.
* Preparation and participation in audits / inspections by clients or official organizations.
* Participate in the management of Quality aspects of Clients / Projects (as project manager or as Quality batch manager in a project).
* Participate in the evaluation and improvement of the Quality System in the Site.
Requirements
* Education : Degree in Sciences or Pharmacy.
* Languages (Language and level of proficiency) : High level of English.
* Professional Experience : Minimum of 7 years in Quality Assurance Systems and Validation with senior role.
* Additional knowledge : SAP, quality systems, validation, drug analysis and production processes.
Required profile
* Ability to work as a team.
* Proactivity and problem solving.
* Results-oriented capacity.
* Communication and leadership skills.
* Organization and planning skills, rigor in action.
* Good observation skills.
Location : Getafe, Community of Madrid, Spain
Seniority level : Mid-Senior level
Employment type : Full-time
Job function : Production, Quality Assurance, and Manufacturing
Industries : Pharmaceutical Manufacturing
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