Quality Assurance Specialist for Pharmaceutical Company
hace 7 días
About the Role:
The Senior Quality Specialist will play a crucial role in supporting business success by ensuring compliance with GDP and quality-related activities in the MCO. This includes maintaining the AEMPS license for Wholesale Distribution of medicinal products and medical devices.
Responsibilities:
- Support GxP-regulated activities, including in-country distribution quality, local Health Authority relationships, local quality surveillance, and contract manufacturing/packaging/analytical testing quality oversight.
- Work collaboratively with other GxP and non-GxP functions to focus on patient needs, regulatory compliance, and internal standards and SOPs.
- Provide key stakeholder support in the Iberia MCO on quality matters and initiatives.
- Decide independently on the release, block, or recall of batches as Responsible Person (RP) deputy.
- Support a harmonized quality approach across Portugal and Spain LOCs.
- Manage GxP regulated activities in Spain LOC to ensure compliance with Takeda requirements and local regulations.
- Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs).
- Implement Takeda QMS and ensure ongoing compliance to quality standards and procedures at the LOC.
- Develop and maintain GxP related controlled documents in the LOC Quality Management System.
- Ensure that LOC QMS is implemented and aligned with our needs.
- Support GDP implementation at Spain LOC, including 3PL oversight.
- Ensure all relevant LOC colleagues performing GDP-related tasks are trained before performing activities.
- Manage submissions of MIF/OCABR for plasma products in LOC Spain/Portugal.
- Manage submissions of import/export permits for controlled substances in LOC Spain/Portugal.
- Implement Supplier Quality Program at Spain LOC according to Takeda Global Quality requirements.
- Perform self-assessments to monitor compliance with applicable procedures and requirements.
- Manage inspections/audits and ensure LOC audit/inspection readiness.
- Lead or support local Health Authority communication on product quality issues.
- Maintain oversight of contracts and quality agreements on LOC level.
- Help prepare external quality agreement between business partners and TPI-IB and/or Manufacturing release sites.
- Support regulatory surveillance and intelligence in the Spanish LOC for new or emerging regulations.
- Ensure there is quality oversight of local GVP/Devices/Medical related activities.
- Ensure release to market activities in the Spain/Portugal LOCs are performed to enable continuous market supply.
- Support any GDP/GxP quality-related activities across the Iberia MCO.
- Local GxP Training administrator for LOC Spain/Portugal.
- Strengthen Quality Culture at LOC.
What you bring to Takeda:
- Pharmacy master degree
- 5 years of job experience in Pharmaceutical company in QA environment
- Experience and proven track record in quality assurance and deep understanding of EU and local laws, regulations and Industry codes related to QA
- Ability to lead by influence and conflict management
- Fluent in written and spoken English
- Knowledge of the regulations in the Geographic Scope and EU
- Deep understanding of LOC/Commercial Quality requirements
- Ability to drive change by influence
- Understanding of industry, scientific and regulatory trends in the Geographic Scope, and its market conditions and requirements
Salary: €60,000 - €80,000 per annum, depending on experience.
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