Requirements: English
Company: FAMAR
Region: Madrid , Community of Madrid
About FAMAR
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 FAMARs 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.
Validation Technician (Process, Cleaning and Transport)
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.
Main Responsabilites:
- 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