Senior Quality Specialist
hace 2 semanas
This is a senior role that requires expertise in quality management and regulatory compliance.
About the Role- Ensure quality management systems are implemented and maintained in accordance with relevant regulations, local legislations, and company policies.
- Oversight of outsourced distribution partners to guarantee compliance.
- Establish corrective actions and promote continuous improvement in critical processes.
- Coordinate with customers, MOH, and other stakeholders on returns, market actions, complaints, and inquiries.
- Batch release documentation of products to ensure quality, including incidents and complaint resolution.
- Training activities in quality areas and management of staff training records for GxP positions.
- Change control and 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 and 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.
We are seeking a highly skilled professional with:
- Bachelor's Degree in Pharmacy.
- At least 6 years of experience in the Pharmaceutical Industry, primarily in 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.
€60,000 - €80,000 per year, depending on experience.
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