Senior Qualific & Validation Specialist

UNAVAILABLE; Lisboa; Presencial; EUR 40 000 - 60 000; Tempo integral

Resumo da oferta

Hovione, a renowned Contract Development and Manufacturing Organization, seeks a Quality and Qualification Specialist in Lisbon, Portugal. In this role, you will define procedures to ensure compliance with quality standards and manage qualification and validation processes. The position requires a university degree in Chemistry or Chemical Engineering and 5-8 years of experience in a quality assurance role. Fluency in English and strong analytical skills are essential. Hovione values diversity and is an equal opportunity employer.

Qualificações

• 5–8 years of relevant experience in Quality and Qualification and Validation in an industry environment.
• Advanced knowledge of Quality, Engineering, cGMP, ICH and ISO guidelines.
• Must be fluent in English.

Responsabilidades

• Define and implement procedures to assure compliance with quality standards.
• Coach/train quality teams promoting continuous improvement.
• Manage and approve qualification and validation protocols.

Conhecimentos

cGMP compliance

Quality standards

LEAN 6-Sigma

Risk assessment

Analytical skills

Formação académica

University or equivalent qualification in Chemistry or Chemical Engineering

Ferramentas

MS Office

Descrição da oferta de emprego

Join a Market Leader

At Hovione, we help partners turn scientific innovation into medicines that reach patients around the world. For more than 65 years, we have connected science and technology to scale complex ideas into high-quality and innovative solutions that truly make a difference.

As an international Contract Development and Manufacturing Organization (CDMO), we support the development and manufacture of drug substances, intermediates and drug products across the full life cycle. We are globally recognized for our leadership in specialized technologies such as Spray Drying and Continuous Tableting. But what truly sets us apart is not just what we do – it is how we do it: with purpose, care, collaboration and a deep commitment to doing the right things right.

Our people are the reason for our success. We are a global and diverse team of more than 2,600 team members across Europe, the USA and Asia, bringing together different experiences and perspectives to help our partners to overcome complex challenges. We believe that an inclusive environment – where everyone, regardless of background, identity or ability, is respected, heard and empowered to contribute – is essential to drive innovation, ensure quality, and secure long‑term sustainable success.

And as we grow, so do the opportunities for our people to develop, broaden their perspectives and build meaningful careers. Because at Hovione, better starts with those who choose to make a difference every day. Will you be one of them?

Responsibilities

Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.

• Assure cGMP compliance in the activities related to Qualification and Validation of systems/equipment (production & analytical), 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 outstanding service.
• Review and propose changes to the required corporate procedures that regulate 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 Hovione Site, and any major projects for Corporate functions, in order to assure GMP compliance.
• Compliance against applicable guidelines.
• Plan and/or establish Qualification and Validation requirements for each project.
• Establish the required qualification activities for new or changed systems and/or facilities within the change control process.
• Prepare/approve VMP for projects of each site, approve the VMP for major projects and support project execution at each site, for corporate functions.
• Approve pre‑ and post‑execution Qualification and Validation protocols as well as final VMP report (for major projects) and other systems’ related documentation such as periodic reports.
• Review reports at site level, participate or support internal or external/customer audits and health authority inspections.
• Control, close and 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/analyze with significant impact on business and coordinate work/activities within the team.
• Make quality and timely decisions based on multiple sources of data.
• Manage risk and uncertainty; anticipate and address roadblocks to prevent deviations to the goals.
• Carry out assigned tasks and duties safely, in accordance with instructions, and to comply with environmental, health & safety rules, procedures, regulations and codes of practice.
• Promote the importance of management through the applicability of LEAN tools and other relevant methods for the area objectives.
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements and promote the implementation and maintenance of Hovione’s policies, systems, and procedures (COPs, HBR, SOPs and others).

Candidate Requirements

• University or equivalent qualification in Chemistry, Chemical Engineering or a similar scientific field (mandatory).
• Typically requires 5–8 years of relevant experience in Quality and Qualification and Validation in an 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 tasks in accordance with the rules and procedures set down.
• Fluency in English (required).
• Computer literate with good working knowledge of the MS Office package.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.