ALTEN Spain , a leading force in the IT, Engineering and Life Sciences industries.
We are currently seeking a dedicated and skilled Quality Specialist GDP .
ALTEN Group Within 30 years, ALTEN has become 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 person will be key to ensuring that quality processes are performed efficiently and adhere to regulatory requirements by resolving issues, optimizing the system, and training end-users.
Responsibilities: Contact with warehouses and carriers (GDP environment).
Release for distribution for medicinal and non-medicinal products.
PQRs review & approval.
Complaints management & trend analysis.
Recall management.
Returns management.
Guarantee the Quality standard application related to the pharmaceutical activity (EU GDP's) in Spain.
Local QMS maintenance including deviation, CAPAs & follow up and any other related activity.
Local Change Control management & involvement in any related activity derived from global Change Control.
Assist to the Quality Audits received from authorities or others.
Process owner for Quality Systems processes and ensure continuous improvement and harmonization is done aligned with Global Quality Head.
Ensure oversight of Supply Chain for products acting as MAH is in place and covered for global functions.
Promote Quality culture and GDP, MMDD, Cosmetics, Biocides and Food supplements regulation to all stakeholders in the commercial affiliate.
Give support to Quality Iberia unit in activities related to the compliance of EU-GDP.
Requirements: At least 3 years of experience in in the Quality area in distribution (GDP).
Knowledge of quality management processes and regulatory requirements in the pharmaceutical or biotechnology industry.
Knowledge of Spanish regulations.
Self-motivated with a high level of task prioritization.
Proactive profile with adaptability to change.
Intermediate-high level of English (minimum B2), some documentation is in English.
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 Continuous trainings Possibility to join different and interesting projects If you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you