Crear una alerta de empleo para esta búsqueda
About FAMAR
FAMAR is a European provider of pharmaceutical development and manufacturing (CDMO) services with a legacy of 75 years of technological experience. Based on its experience, FAMAR is a reliable partner to offer flexible solutions, from development to production and distribution. Continuity and customer service are the pillars of FAMAR's long-term business partnership. Through the commitment of 1800 employees worldwide and with a network of 6 Production Plants in Europe, FAMAR supplies a wide range of over 1800 products in a variety of dosage forms in 80 international markets.
Mission
Manage quality systems (Change Control, Suppliers Claims and CAPA), as well as Audits, Inspections and Self-inspections, in accordance with current regulations and the company's procedures and policies for the manufacturing, analysis and distribution of pharmaceutical products and health products.
Main responsibilities
1. Participate in the management and coordination of quality systems (Change Control, Claims and CAPA).
2. Coordinate the execution of external audits / inspections (in-person activity in back room and front room). Prepare the necessary documentation previously requested in the Agenda.
3. Prepare the Site annual self-inspection Plan and ensure its execution.
4. Manage the Corrective and Preventive Action Plan (CAPA Plan) from external audits, inspections by official organizations and self-inspections.
5. Manage and coordinate the maintenance of GMP authorizations of official organizations.
6. Participate in Audits / Inspections (Agencies, Clients and Corporates) as an audited party.
7. Perform Risk Analysis.
8. Periodically prepare reports on your area of competence.
9. Participate in the evaluation and improvement of the plant's quality system.
10. Participate in the evaluation and monitoring of the annual quality program.
11. Participate in the development and monitoring of the plant's quality indicators (KPIs).
12. Write, supervise and keep updated the procedures linked to your activity and ensure their application.
13. Ensure annual ISO 9001 and ISO 13485 revalidation in your area of responsibility.
14. Guarantee the management and implementation of new regulations.
15. Participate in improvement projects.
Requirements and experience
1. Training: Higher in Sciences or Pharmacy.
2. Languages (Language and level of proficiency): High level of English.
3. Professional Experience: Minimum of three years in the pharmaceutical industry.
4. Additional knowledge: Suppliers, TrackWise, SAP, Drug analysis and production processes.
Profile required
1. Ability to work as a team.
2. Organization and planning skills, rigor in action (daily organization, writing documentation...)
3. Communication skills.
4. Proactivity and problem solving.
5. Results-oriented ability.
6. Own initiative.
Location
Alcorcón (Madrid)
#J-18808-Ljbffr