Operations Quality Specialist, Lisbon Lisboa

Operations Quality Specialist, Lisbon
Lisboa
Lisboa, Lisboa, Portugal

Marketing Company Operations Quality Specialist

Introduction to Role:

Join our team as a Quality Specialist, within the global organization Marketing Company Operations Quality (MCOQ), where you'll manage all required activities, tasks, and processes to ensure compliance with Good Distribution Practices of Medicinal Products for Human Use (GDP), local laws and regulations, and Astra
Zeneca's internal requirements for GMP and GDP. This is your chance to accelerate our Lean journey and drive efficiencies in our processes!

Act as a back up of the Astra
Zeneca Technical Director, for the wholesaler distribution activity of medicinal Products in Portugal.

Accountabilities:

As a MCOQ Specialist, you will develop, support, and drive excellence in the Astra
Zeneca GMP/GDP Quality Management System (QMS), ensuring compliance with specific legal requirements in the Country.

You'll be responsible for a wide range of activities within the QMS, including:

1. Maintaining the Local Quality manual and Local SOPs/Work Instructions
2. Managing change control, deviations, complaints, and customer/supplier management
3. Conducting
   - inspections and training
4. Managing CAPA, risk assessment, and quality performance tracking
5. Local batch approval for sale and management of returns with potential for stock reintegration
6. Technical and regulatory interface/support with Logistics Service Provider and other Astra
   Zeneca relevant functions

As a back up for the Technical Director, ensure compliance with Good Distribution Practices of Medicinal Products for Human Use and applicable laws and regulations, contributing to audit and inspection readiness status, so that the business maintains its license to operate and public service obligations are met.

Minimum Requirements:

• University Degree in Pharmacy/Pharmaceutical Sciences
• Fluent in local language and English
• Demonstrated
  - level knowledge on Good Distribution Practices of Medicinal Products for Human Use, applicable laws and regulations
• Experience in quality assurance within the pharmaceutical manufacturing or distribution environment, including compliance reporting and quality performance tracking
• Experience with computerized pharmaceutical quality management systems
• Good understanding and knowledge of
  - related processes
• Strong teamwork skills
• Strong adaptability and flexibility
• Ability to manage multiple tasks and priorities simultaneously
• Ability to work under strict timelines, with flexibility for emergencies
• Focus on internal and external customers, assessing and prioritizing their needs
• High ethical standards

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire
- changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office, while respecting individual flexibility.

Why Astra
Zeneca?

At Astra
Zeneca, our work in Quality is important and valued. We're always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes. We're proactive,
- based,
- oriented, and our ambition keeps pushing us forward. We focus on
- centricity, constantly asking what more we can do to deliver to patients safely. Join us as we continue to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies, and growing areas like biologics.

Ready to make a
- life difference to patients? Apply now and join our ambitious team!