Senior Quality Specialist
hace 2 semanas
This position is responsible for ensuring the quality of Takeda products in the Iberian market. The successful candidate will implement and maintain a quality management system in accordance with local and international regulations, as well as Takeda's policy.
Key Responsibilities:
Quality oversight of outsourced distribution partners
Ensure compliance with legal and corporate requirements, as well as I-SOPs and Local SOPs
Establish corrective and preventive actions and promote continuous improvement in critical processes from a quality perspective
Collaboration with Local Stakeholders:
Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing
Quality Management System:
Batch release documentation of the company products to ensure quality, including incidences and complaints solving
Training activities in the quality area and management of staff training records for GxP positions
Change Control & CAPA management and monitoring
Management Review Systems and Quality Council meetings
Collaboration in QMS maintenance
Handling of returns and management of returned products
Control of damaged and broken products
Local Complaint Coordinator & management of counterfeit products
Technical Support:
Responsible for Annual Environmental Declarations
Control of free samples distribution and storage in accordance with national law
Supplier approval and maintenance
Ensure timely delivery of fully compliant products applicable to local regulations
Control of narcotics / controlled substances according to National legislation
Participation in internal and external audits and collaboration with CAPA plans follow-up
Management of enquiries related to the technical / quality department
SOPs & Document management, collaboration in Global procedures implementation at the local level
Promote Takeda-ism philosophy and values
Communicate adverse reactions to the pharmacovigilance department
Requirements:
Bachelor's Degree in Pharmacy
Practical experience of at least 6 years in the Pharmaceutical Industry, primarily in a QA environment
Supply Chain knowledge is beneficial
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