randstad candidatos ofertas de empleo volver Técnico De Validaciones

Técnico De Validaciones en Lliçà d'Amunt, Barcelona.

02 Abr 2022 publicado por Professionals

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tipo de contrato
jornada laboral
sector empresa
Química Farma
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responsable validaciones
Lliçà d'Amunt
Life Sciences
Pharma y Biotech - Producción
Combinada (teletrabajo y presencial)
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To guarantee that the standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where Biokit sells product. Assure that all products manufactured at Biokit are designed, manufactured and released according to established procedures. Assure that all facilities, utilities and equipment involved in the production of all products manufactured at Biokit complies with defined standards. Assure the proper implementation of good quality practices in all processes at Biokit and be able to identify improvement opportunities necessary to contribute to the robustness of the Biokit Quality System.

our client

Importante Empresa Multinacional del Sector Farmacéutico.

your functions

¿ Review and approval of manufacturing procedures, general procedures or instructions¿ Change Management: evaluate the impact of the proposed changes, approve action plan proposal and its implementation.¿ Validation/ Qualification: Review of qualifications for facilities, equipment and utilities, including qualification strategy, execution and management of potential deviations detected.o Factory acceptance Test (FAT) / Site acceptance test (SAT) execution / approval.o Review of process validations, including validation strategy, execution and management of potential deviations detected.o Be able to establish a strategy to validate changes. Review validation strategies and the corresponding documentation (protocol and report)¿ Risk Assessment: o Carry out, review and approve the risk assessment performed at Biokit to evaluate the impact of changes in the final product.¿ Provide training in validation & risk management to Biokit staff to ensure that the organisation is both skilled in implementation and is utilising best in class methodologies¿ Participate in Internal and External Audits as needed¿ Perform Quality Training to all personnel at Biokit.¿ Management of Non-conformances and CAPA¿ Ensure that validation lots are appropriately tested, reviewed and released¿ Implement new procedures and instructions as a result of the observed practices on site to contribute to the Quality System robustness.¿ Be proactive regarding the continuous improvement in Quality processes and procedures

position requisites

¿ Education: o Required: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology or other Sciences. o Degree may be substituted by relevant skills and work experienceo Valuable: Any additional degree higher than the required ¿ Experience: o Required: 3 years in a similar position ¿ Additional Skills/Knowledge:o Software: Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAPo Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking)o Standards: Knowledge of Quality standards

The ideal candidate for this position will exhibit the following skills and capabilities: - Management of decisions under pressure. - Methodical and well-organized person.- Teamwork- Time management skills- Ability to express information clearly and concisely to the staff, ensuring their understanding.- Ability to apply a systematic approach and constant control, follow-up and verification of the results.- Ability to collaborate, participate and coordinate actively with working groups- Reflects values of Werfen in the quality of work and working relationship

  • Formación: Grado: Grado en Biotecnología, Grado: Grado en Química
  • Idiomas: Inglés: B1
  • Conocimientos: SAP
  • Experiencia: 3 años
your benefits
Oportunidad de carrera y desarrollo dentro de una empresa líder del sector. Horario Flexible con Opción de Teletrabajo. Contrato Indefinido.
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