Stability Manager-Biologics

hace 4 semanas

Guadalajara, Jalisco, México AstraZeneca A tiempo completo

Why AstraZeneca?

Join a team that supports the delivery of life-changing medicines for patients by enabling the rest of the business to run effectively and harness our entrepreneurial science. We're on a journey of growth and evolution. to find better ways to translate value for the business and our patients. We're always adapting and challenging the status quo, it's what helps us to succeed. But it's not change for change's sake. It's about working together seamlessly and inclusively, sharing ideas to find a better way. As a multi-cultural team, we are a winning combination of deep process knowledge, eye for business and hard work. We always go above and beyond for the collective good of the team. And with a deep personal connection to our patients, there's nowhere we'd rather be.

Ready to make a difference? Apply now

Positions are open to Mexican Citizens and official residents of Mexico.

Location: Guadalajara (hybrid: 3 days in the office & 2 from Home)

Strong English communication skills required.

Job Title: Stability Quality Assurance Manager.

Introduction to role:

The Global Stability Management (GSM) Team sits within Global Quality Control & Stability. The team handles and provides stability expertise for technical issues. The group designs and leads an optimised global stability programme to supervise and ensure the quality of our products throughout their shelf life. The team acts globally and support all product licenses in all markets. The group operates in the interface between the operation sites, stability testing sites and the regulatory function. It has prime accountability for proactive and focused support on all aspects of stability management for all global operations sites. The team has a regulatory and technical focus.

We have now an exciting opportunity for you to join this outstanding team in a role as Stability Quality Assurance Manager.

In this role, you will join our dedicated Global Stability Management team, and we will look to you to demonstrate your quality assurance as well as technical expertise to support our new and established products.

Accountabilities:

You will be responsible for assuring that a commercial product portfolio is handled in compliance with AstraZeneca's commercial stability obligations. You will use your expertise to analyse stability information and data to support license management for global products. You will also need skills to influence partners and project team members.

Your role will involve the strategic and technical assessment of supply chain changes, process and packaging changes, and translating findings into the appropriate programmes of stability studies.

The Stability Quality Assurance Manager it's responsible for overall surveillance of data, stability profiles and issues arising from the global commercial stability program. Participate in investigations involving multiple functions from the supply chain of affected products and assure the integrity of stability study reports intended for submission to regulatory agencies. You will also be required to identify issues that may lead to non-compliance with GMP, regulatory requirements and commitments, and advise on areas for improvement across Global Stability Management.

Essential Skills/Experience:

  • Educated to Degree or Equivalent experience in a science field
  • Experience in Regulatory, QA/QC or pharmaceutical development in a Pharmaceutical or related Industry
  • Strong data handling skills and an understanding of the importance of data integrity

To truly thrive in this role, you need to have a well-developed ability to analyse qualitative and quantitative stability information. This in order to draw conclusions and make recommendations, based on clear scientific rationale.

At AstraZeneca, we take Quality seriously. Our work is relevant and valued. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. We are a team of bold people, who want to go far and we're all here to achieve. We follow evidence to reach outcomes that benefit patients and AstraZeneca. With our digital and Lean evolution in Operations, we have a sharp focus on patient-centricity, constantly asking what more we can do to deliver to patients safely.

Are you ready to join a team that is proactive, science-based, solutions-oriented, and committed to delivering what will have the biggest impact on our patients? Apply now

Date Posted

09-May-2024

Closing Date

09-Jun-2024

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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