ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries.
We are currently seeking a dedicated and detail-oriented Commercial Quality Specialist in a GDP environment with experience in batch disposition activities, technical complaints management, ensuring regulatory compliance, and supporting CAPA activities within regulated pharmaceutical and life sciences distribution environments.ALTEN GroupWithin 30 years, ALTEN has become a leader in both outsourced Engineering and IT Enterprise Services.
ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications.
We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.Do you want to work in exciting projects at renowned clients?
At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success.
Our consultants make the difference.
Do you want to make the difference too?
This role as a Commercial Quality Specialist in a GDP environment requires a strong understanding of quality systems, batch disposition, and quality compliance, along with the ability to work cross-functionally to identify, assess, and mitigate compliance and quality risks in accordance with Good Distribution Practices (GDP), applicable regulatory requirements, and Quality Risk Management principles.Key Responsibilities- Perform batch disposition activities for human and veterinary medicines to assess compliance with Good Distribution Practices (GDP) and internal quality requirements.
- Review and assess GDP-related documentation, including SOPs, batch records, and quality systems.
- Manage technical product complaints, quality incidents, deviations, and CAPAs, ensuring that records are complete and accurate and that these issues are tracked until resolution.
- Support the development and implementation of CAPA (Corrective and Preventive Action) plans.
- Ensure compliance with applicable regulatory requirements and quality standards (e.G., GDP guidelines, internal quality procedures).
- Act as a focal point for quality-related issues, coordinating with customers, 3PLs, and internal stakeholders (Supply Chain, Regulatory Affairs, and Sales teams).
Qualifications- 2 years of experience in the pharmaceutical industry in quality roles related to GDP.
- Bachelor's or Master's degree in Pharmaceutical Sciences and active registration with the Portuguese Pharmaceutical Society.
- Proven experience in reviewing GDP documentation, performing audits, and ensuring compliance with Good Distribution Practices (GDP).
- Ability to work cross-functionally with Logistics, Supply Chain, Quality, Validation, and external service providers.
- Experience in quality risk management, deviation handling, and CAPA development and follow-up.
- High standards and attention to detail, critical thinking, a risk-based approach, autonomy, and the ability to make pragmatic decisions.Location: Lisbon (Hybrid)Why Join Us?
- Possibility to work with cutting-edge technology in the Life Sciences industry.
- Collaborative and dynamic work environment.
- Possibility to join a top-leading company in the industry.
- Possibility to join different and interesting projects.
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