QA SPECIALIST

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Job 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 product for human use (/C ); with local and relevant international regulations, local and international legislations, ISO 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 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 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 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 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