Senior Quality Specialist
Responder al anuncioAbout the role :
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), 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 :
- 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.
- Local quality surveillance connects with customers: Returns, market actions, complaints, inquiries.
- Maintain good relationships with the Local MOH for Good Distribution Practices inspections and work closely with RA in MOH communications.
- Support geographic expansions and brand plan launches.
- Shipping validation and distribution processes quality oversight.
- Contribute to the identification of risks in the quality area, CAPA proposal, and follow-up.
- Interact 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.
- Resolve technical requests regarding products: storage, manipulation, expiry, and administration.
- 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.
What you bring to Takeda :
- 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.
- Experience in supporting inspections from local authorities/global audits.
- Strong interpersonal skills.
- Ability to manage multiple and complex priorities.
- Excellent verbal and writing skills, fluent in English.
Knowledge :
- Good knowledge of Pharmaceutical Quality Management systems: EU GDPs, ISO standards, GMPs.
- Excellent knowledge of local GDP and Controlled Substances regulations.
More about us :
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work.
Locations: Madrid, Spain
Worker Type: Employee
Time Type: Full time
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