- Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
- Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
- Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
- Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
Quality Assurance External Sites Specialist - SAB - PHARMA SANT ANDREU DE L, España - Almirall
Descripción
Misión
Ensure GxP compliance in subcontracted manufacturers management of the Almirall group's pharmaceutical products.
Funciones y responsabilidades
New business and cross functional projects
• Integration and maintenance of CMO portfolio in ALM IT systems; Trackwise SQM, Official List & SKUs
• Participation in cross functional teams and projects of CMO products
CM Quality Management System
• Data collection for Risk assessment of products and CMOs
• Execution of assigned activities/projects for the defined Annual plans
• Ensure implementation of KPIs
• Identify and propose improvement actions in CM QMS
• Review and maintenance of CM QMS SOPs
Quality oversight of CMOs
• Maintenance of QA agreements
• Follow-up of implementation of CAPAs from audits and inspections
• Participation in GMP audits
• Identify, propose and execute improvement actions in CMO performance
Quality oversight of products
• Record and follow-up of quality events: change control, OOS, deviations and CAPAs
• Collection of PQRs from CMOs
• PQRs initial validation and submit for approval (eDMS)
Product and MA compliance
• Follow-up of specific plans related to implementation of new regulations
Regular supply
• QA Support to regular supply and market disposition when applicable.
QA CM development
• Ensure fluent and effective communication with internal and external stakeholders
Formación
Education: Bachelor Degree in Life science (Pharmacy, Chemistry, Biological sciences or similar subject)
Conocimientos específicos
Good knowledge and skills in the use of advanced personal computer programs and systems such as Trackwise and eDMS.
Ability to influence and collaborate with others, negotiation and proactivity.
Languages: Advanced written and verbal communication skills in Spanish and English.
Travelling and moving availability.
Experiencia
2/3 years experience in GMP fabrication environment and contract manufacturers management