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Atualizado 15/12/2022
- Senior Qualification & Validation
- Chemicals
Sobre o nosso cliente
Large multinational.
Descrição
- Assure cGMP compliance in the activities related to Qualification and Validation of systems/equipment, utilities and facilities, throughout their lifecycle
- Coach/train Sites' Quality and Operational areas, promoting a culture of continuous improvement standards in such a way as to guarantee the fulfilment of latest applicable regulations
- Promote the Qualification and Validation vision and energize less experienced team members to provide an outstanding service
- Review and proposed changes to the required corporate procedures that regulates Qualification and Validation activities to align and harmonize with associated disciplines/ areas (e.g.: preventive maintenance, calibration, Engineering, Digital (Automation/IT), Quality Control, when applicable, etc.)
- Guarantee the fulfilment of the applicable Quality and Regulation requirements in all projects under own responsibility
- Assure a Risk based approach in the Qualification and Validation related activities
- Answer and give guidance on Qualification and Validation subjects to Client and Health Authorities' requests
- Participate in Conceptual, Basic and Detailed design review for Projects of each 's Site, and any major Projects for Corporate functions, in order to assure the GMP
- Compliance against applicable Guidelines
- Plan and/or establish Qualification and Validation requirements for each project
- Establish the required qualification activities of new or changed systems and/or facilities within the change control process
- Prepare/approve VMP of Projects of each Site, approve the VMP for major Projects and support Project's execution at each Site, for Corporate functions
- Approve (pre and pro execution) Qualification and Validation protocols as well as Final VMP Report (for major Projects) and other systems' related documentation such as Periodic
- Review Reports, at Site level Participates or support internal or external/customer audits and health authority inspections
- Control/close/approve deviations, CAPA, improvement plans, and change control related to Qualification and Validation of Systems Master Qualification and Validation processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
Perfil ideal
- University, or equivalent, qualification in Chemistry, Chemical Engineering, Mechanical Engineering or similar scientific field (mandatory)
- Typically requires 5-8 years of relevant experience in Quality and Qualification and Validation in industry environment
- Advanced knowledge of Quality, Engineering, cGMP, ICH and ISO guidelines, Risk Assessment applied to Qualification and Validation and LEAN 6-Sigma with the ability to solve complex problems
- Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
- Fluency in English is a requirement
- Computer literate with good working knowledge of the MS Office package
Vantagens
A great professional opportunity.
Pesquise mais Ofertas
Pedro Prata
Quote job ref
JN-102022-5781672
Resumo da Função
- Subsetor
- Químico/Processo
- Indústria
- Healthcare / Pharmaceutical
- Localização
- Lisboa
- Tipo de contrato
- Indefinido
- Nome do Consultor
- Pedro Prata
- Referência da Oferta
- JN-102022-5781672
