Description
This role will be responsible for Quality activities in relation to Takeda Products commercial activities at Takeda Iberia Local Operating Company (LOC) which includes ensuring that a quality management system is implemented and maintained in accordance with the Guidelines on Good Distribution Practice for medicinal products for human use (2013 / C 343 / 01); with local and relevant international regulations, local and international legislations, ISO 14001 requirements (in the case of TFE) and with Takeda policy.
Key activities of the role:
In country Distribution Quality- Quality oversight of outsourced distribution partners
Ensure the compliance of legal and corporate requirements, as well as the I-SOPs and Local SOPs.
Establish corrective and preventive actions as required and promote continuous improvement into the critical processes from a quality point of view of the company.
Local quality surveillance connects with customers: Returns, market actions, complaints, inquiries
Local MOH relationship- Good Distribution Practices inspections & Work closely with RA in MOH communications
Support geographic expansions and brand plan launches
Shipping Validation and Distribution processes quality oversight
Interaction with Local Stakeholders: Supply Chain & Customer service, Customers, Pharmacovigilance, Regulatory Affairs, Compliance, Suppliers, Medical Affairs, Marketing
ACCOUNTABILITIES:
In relation to Takeda products and distribution:
Quality Management System:
Batch release documentation of the company products (reviewing packaging materials of each batch and FMD compliance) to ensure the quality of Takeda products released including incidences and complaints solving.
Training activities in the quality area and management of staff training record for the Medical Affairs department and GxP positions.
Change Control & CAPA management and monitoring.
Management Review Systems, Quality Council meetings. Collaboration in QMS maintenance.
Market action.
Handling of Returns. Management of returned products to our local warehouse and destruction process through an authorized company.
Control of damaged and broken products.
Customer BonaFide.
Local Complaint Coordinator & management of counterfeit product.
To resolve technical requests of the products: storage, manipulation, expiry and administration.
Responsible for Annual information to SIGRE regarding Takeda products as well as Declaración de envases industriales to the CAM.
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.
Import / Export requirements manage temperature excursions and transport distribution deviations, Local Release, MoH local Plasma Product Release.
Control of narcotics / controlled substances and hemoderivates according to National legislation. Management and authorization of narcotics vouchers and request for marketing authorization of blood products batches via AEMPS.
Traceability of the Takeda products:
Participation in internal audits and external audits and collaborate with CAPA plans follow up / audits closeout.
To ensure implementation and maintenance of Quality Management System according to National legislation, corporate requirements and ISO 14001 requirements.
Management of enquiries related to the technical / quality department.
Artworks control sheets management.
SOPs & Document management. Collaboration in Global procedures implementation at local level. Act according to Corporate, Compliance, Ethical codes and Legal standards.
Promotes, encourage and demonstrate commitment to Takeda-ism philosophy and values.
Communicate to pharmacovigilance department any adverse reaction at the time of becoming aware of it, following company's internal procedures.
Participate in the development and implementation of an annual quality plan within the scope of responsibility.
Management of informatics systems used in Quality department (NewFile, CLIX, LEADS, EQMS, SAP, Trackwise).
Health Authorities communications to assure GDP compliance.
Quality Activities: Warehouse and Distribution activities
Overseeing audit of the quality system on a regular basis, tracking and assisting in the closure of Internal (corporate and self-inspection) and External Audits 3rd party storage and distribution sites.
Prepare and review Local Quality Agreements and Warehouse and Distribution Agreements.
Accountable for Quality KPIs metrics.
Assist the Supply Chain Organization to ensure continuity of supply is maintained.
Additional activities
Contribute to develop and strengthen global quality management systems and provide flexible support to business both at the country level and global level.
Support to Quality Head / Lead / RPs within the country.
Ensure inspection readiness in market.
Support ongoing integration projects at Takeda associated with Distribution and Supply.
EDUCATION, EXPERIENCE, SKILLS, KNOWLEDGE
Education:
Bachelor's Degree in scientific discipline.
Experience:
Practical experience of at least 3 years in the Pharmaceutical Industry, a majority of which has been gained in a QA environment.
Supply Chain knowledge is beneficial.
Experience in supporting inspections from local authorities.
Experience of working with suppliers and customers.
Experience in working in a global and matrix environment.
Skills:
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team.
Locations: Madrid, Spain
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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