QA Specialist
Takeda
- Madrid
- Permanente
- Tiempo completo
- 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 requires and to promote the continuous improvement into the critical processes from 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
- 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 and authorized company.
- Control of damaged and broken products.
- Customer BonaFide
- Local Complaint Coordinator & management of counterfeit product.
- To resolve technical request 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 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,
- Health Authorities communications to assure GDP compliance.
- 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.
- 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:
- Bachelor’s Degree in scientific discipline.
- 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
- 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