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 (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 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 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 a 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

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