Senior Quality Specialist, Portugal/Iberia
2 semanas atrás
As a Senior Quality Specialist in our Lisbon, Portugal location, you will be responsible for leading quality assurance efforts to ensure compliance with regulatory requirements and internal standards.
Key Responsibilities- Quality Management System Implementation: Ensure that our Quality Management System is implemented and maintained, focusing on the management of authorized activities and the accuracy and quality of records.
- GxP Training Administration: Manage GxP training for local personnel, ensuring they are properly trained prior to performing activities.
- SUPPLIER QUALITY PROGRAM: Implement and maintain a Supplier Quality Program at our Portugal location, according to Takeda Global Quality requirements and regulatory expectations.
- Audit Readiness: Ensure our Portugal location is audit-ready at all times, managing inspections/audits and implementing corrective actions as necessary.
- Regulatory Compliance: Stay up-to-date with industry trends, scientific and regulatory developments, and market conditions, ensuring we remain compliant with EU and local regulations.
- Leadership and Collaboration: Collaborate with cross-functional teams to drive change, improve performance, and maintain compliance, demonstrating strategic enterprise thinking and finding innovative ways to serve patients.
- Portuguese Pharmacy Degree: You hold a degree in pharmacy from a recognized institution.
- QA Experience: You have at least 5 years of experience in QA within the pharmaceutical industry.
- Languages: You are fluent in written and spoken English.
- Technical Skills: You possess strong knowledge of EU and local regulations, as well as GxP requirements.
We offer a competitive salary range of €80,000 - €110,000 per annum, commensurate with experience, plus benefits, including health insurance, pension scheme, and paid time off.
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