Company Description
STEPSCIENCE - PHARMA & ENGINEERING specializes in providing compliant, innovative, and scalable consulting services to the pharmaceutical, medical devices, biotech, and life sciences industries.
With expertise in GMP compliance, CQV (Commissioning, Qualification & Validation), and Pharmaceutical Engineering, we support clients Globally. STEPSCIENCE offers cross-industry knowledge in highly regulated environments, delivering cost-effective and client-specific solutions.
The company has a proven track record in streamlining processes for the industry and is recognized as a preferable partner when things need to be done right.
Role Description
This is a full-time, hybrid Quality Assurance Consultant role based in Paço de Arcos.
As Quality Assurance Consultant you will oversee the development and implementation of quality assurance systems and processes to ensure compliance with regulatory and industry standards.
Main responsibilities:
Support the implementation, maintenance, and improvement of Quality Management Systems (QMS) according to EU GMP, FDA, ICH, and other standards such as ISO 9001:2015.
Conduct gap assessments and audits (internal/external,) and prepare detailed reports with actionable recommendations.
Participate in the preparation and revision of controlled documents such as SOPs, quality manuals, forms, and technical reports.
Assist operations and client's quality function in tracking, documenting, and reporting quality levels.
Provide outsourced services directly at client facilities in alignment with project or operational needs.
Support clients in preparing regulatory submissions and license applications to authorities (e.g., Infarmed I.P., EMA, FDA) for pharmaceutical and related industries (medicines, cosmetics, medical cannabis, etc.)
Prepare and deliver GxP training sessions using Stepscience methodologies and contribute to the development of new training content and tools.
Ensure project deliverables are completed on time, within scope, and aligned with client expectations.
Collaborate with multidisciplinary project teams and maintain effective communication across functions.
To work with the project team being an aggregating element, opening communication channels between all relevant stakeholders to promote achieving the project goal.
Qualifications and Key Competencies
University degree in Pharmacy, Engineering (Chemical, Mechanical, Electrical) or equivalent scientific field
Minimum of 2 years of experience in Quality Assurance processes (deviation, complaints and change control management, PQR execution, client qualification, batch documentation review, ...)
Proven experience in leading QA/QMS implementation or remediation projects.
Understanding of regulatory requirements and industry standards
Excellent attention to detail and problem-solving skills
Effective communication and collaboration skills within multidisciplinary teams
Fluency in English, spoken and written.
Valid Driver's Licence
What you can expect
Integration in a well structure and diverse team
Initial and continuous training
Remuneration according to demonstrated experience
Hybrid work policy, depending on project needs
Health Insurance
Flexible benefits platform
Nível de experiência
Assistente
Tipo de emprego
Tempo integral
Função
Controle de qualidade
Setores
Fabricação de produtos farmoquímicos e farmacêuticos