Somos una compañía de recursos humanos con más de 20 años de experiencia que ofrece Servicios de Consultoría de RRHH y de Selección de mandos intermedios, puestos técnicos y perfiles profesionales a nivel nacional e internacional.
Realizamos operaciones en numerosos sectores estratégicos de manera rápida y ágil gracias a la experiencia de nuestros consultores especializados.
Empresa que ofrece el puesto: Pharmaceutical CompanyRealizamos operaciones en numerosos sectores estratégicos de manera rápida y ágil gracias a la experiencia de nuestros consultores especializados.
Madrid 12 Abr.
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Descripción Departament: Quality, RA and PV
Immediate superior's positions: Quality, RA and PV manager
Job Description
Act as Technical Responsible deputy:
Support in the maintenance of the Quality Management System. Ensure the correct functioning of the Management System together with the Technical responsible. Verify and ensure that the Company's products comply with the applicable regulations before placing them on the market. Participation in the necessary reviews of placing on the market of the products that Company commercializes.
Performing the register of the company products and ensuring that all of them comply with the legislation in force. Planning for new launches and coordinating all of them with the rest of the departments involved. Providing support to any other department: marketing department, supply chain, etc.
Act as Pharmacovigilance specialist
Core duties of the job:
Related to Quality Assurance, supporting in the following tasks:
• Acting as Responsible Person (Qualified Person) deputy and ensure compliance with GDP regulation.
• Reviewing the CoA of the batches released by the QP from the manufacturing site and the additional documentation received and ensuring its compliance with the specifications in force.
• Checking the samples sent from each batch to be released to the market
• Preparing release authorizations for the batches to be released in the market.
• Coordinate/perform audits to outsourced suppliers and manufacturers of the company products and company warehouse
Descripción Departament: Quality, RA and PV
Immediate superior's positions: Quality, RA and PV manager
Job Description
Act as Technical Responsible deputy:
Support in the maintenance of the Quality Management System. Ensure the correct functioning of the Management System together with the Technical responsible. Verify and ensure that the Company's products comply with the applicable regulations before placing them on the market. Participation in the necessary reviews of placing on the market of the products that Company commercializes.
Performing the register of the company products and ensuring that all of them comply with the legislation in force. Planning for new launches and coordinating all of them with the rest of the departments involved. Providing support to any other department: marketing department, supply chain, etc.
Act as Pharmacovigilance specialist
Core duties of the job:
Related to Quality Assurance, supporting in the following tasks:
• Acting as Responsible Person (Qualified Person) deputy and ensure compliance with GDP regulation.
• Reviewing the CoA of the batches released by the QP from the manufacturing site and the additional documentation received and ensuring its compliance with the specifications in force.
• Checking the samples sent from each batch to be released to the market
• Preparing release authorizations for the batches to be released in the market.
• Coordinate/perform audits to outsourced suppliers and manufacturers of the company products and company warehouse
Número de vacantes:
1
Modalidad de trabajo:
Presencial
Tipo de contrato:
Indefinido
Ventajas sociales o económicas
• Discuss quality agreements
• Communication with Health Authorities. Handling Health Authorities inspections and external audits related to Quality.
• Performing self-inspections
• Creating and maintaining the GDP Quality System according to the Good Distribution Practices. Creating and reviewing SOPs.
• Product quality complaints effectively management and follow-up. Customer complaints
• Reviewing and registering incidences and No conformities. CAPAs
• Change controls
• Quality metrics, Quality management review
• Reviewing the correct transportation of the products from supplier and/or to customer
• Coordinating product recalls
• Decide on the final disposition of rejected, recalled or falsified products
• Approval of the returns to saleable stock
• GDP training programs
• Approving of new customers and service providers
• Management and updating of Labofar tool (Communicate supply problems, modifications of the MA holder authorization, apply for authorization for exceptional manufacturing, etc.).
• Guarantee compliance with the general procedures approved by the Company and the regulations that regulate the pharmaceutical industry.
• Creating and managing of Company Quality System.
• Creating and managing of internal procedures and instructions. Implementation in the Company structure.
"• Communication with Health Authorities. Handling Health Authorities inspections and external audits related to Quality.
• Performing self-inspections
• Creating and maintaining the GDP Quality System according to the Good Distribution Practices. Creating and reviewing SOPs.
• Product quality complaints effectively management and follow-up. Customer complaints
• Reviewing and registering incidences and No conformities. CAPAs
• Change controls
• Quality metrics, Quality management review
• Reviewing the correct transportation of the products from supplier and/or to customer
• Coordinating product recalls
• Decide on the final disposition of rejected, recalled or falsified products
• Approval of the returns to saleable stock
• GDP training programs
• Approving of new customers and service providers
• Management and updating of Labofar tool (Communicate supply problems, modifications of the MA holder authorization, apply for authorization for exceptional manufacturing, etc.).
• Guarantee compliance with the general procedures approved by the Company and the regulations that regulate the pharmaceutical industry.
• Creating and managing of Company Quality System.
• Creating and managing of internal procedures and instructions. Implementation in the Company structure.
Requisitos
Minimum qualification requirements
• Higher education: Bachelor’s Degree in Pharmacy
• A Master of Science or Doctorate will be taken into consideration
• At least three years’ experience within the Technical Department (RA, QA and PV).
• English: fluent. Portuguese: desirable
• Core competences for the job:
• Strategic thinking, legislation knowledge, decision-making, problem-solving, diligence, accuracy, planning and negotiation skills.
• Higher education: Bachelor’s Degree in Pharmacy
• A Master of Science or Doctorate will be taken into consideration
• At least three years’ experience within the Technical Department (RA, QA and PV).
• English: fluent. Portuguese: desirable
• Core competences for the job:
• Strategic thinking, legislation knowledge, decision-making, problem-solving, diligence, accuracy, planning and negotiation skills.
Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
Ninguna