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Quality Assurance External Sites Specialist, BarcelonaClient:Location:
Barcelona, Spain
Job Category:
Other
EU work permit required:
Yes
Job Views:
3
Posted:
06.03.2025
Expiry Date:
20.04.2025
Job Description:
Ensure GxP compliance in subcontracted manufacturers management of the Almirall group's pharmaceutical products.
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
Education:
Bachelor Degree in Life science (Pharmacy, Chemistry, Biological sciences or similar subject)
Skills:
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.
2/3 years experience in GMP fabrication environment and contract manufacturers management.
* 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.
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