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: 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
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Production, Quality Assurance, and Manufacturing
Industries: Pharmaceutical Manufacturing