Senior Specialist Global Material Certification

📌Positions are open to Mexican Citizens and official residents of Mexico.
📍Location: Guadalajara (hybrid)
📌Strong English communication skills required

Must Submit Resume in English

About the AstraZeneca

AstraZeneca is a global, science-led, patient-focused pharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At Astra Zeneca, we’re dedicated to being a Great Place to work!

Job Description

The incumbent is responsible for the enrolment, periodic verification, and removal of materials from the Certification program in compliance with Global quality management systems for the benefit of supply chain sustainability.  Responsible for key initiatives/projects in collaboration with global key collaborators of Supplier Quality, Quality Control, Quality Systems and Pharmaceutical Development that directly support execution of material Certification.

Accountabilities

Responsibilities:

• This includes, but is not limited to, the Quality System oversight and/or performance of the following activities:
• Author/ Review Certification reports (ECMS)
• Supplier Quality verification as it pertains to material chain of custody (SCA)
• Deviation investigations, quality issue management and customer concern (EQV, IMT)
• Maintain schedule adherence (Demand and Capacity) for all certification subprocesses
• Compendial requirements verification
• Change Control Management (EQV)
• SOP management
• LEAN initiatives to simplify and standardize processes.
• Quality Risk Assessment (QRA)

Key Accountabilities

• Collaborates with AZ Sites to achieve schedule adherence
• Facilitates process and system improvements via voice of customer
• Archiving certification documentation as required
• Set up of automated reporting of results process (through GQCLIMS/power BI)
• Site Liaison contact for QC, PT&D, EQ, etc.
• Initiative and projects supporting certification program and interdependent global processes
• Regulatory Audit support

Requirements

• Bachelor’s degree or equivalent experience in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
• Strong proven knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment.
• Strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
• Excellent oral and written communication skills in English

Specifically required essentials:

•  Ability to work independently under their own initiative.
• Ability to travel nationally and internationally as the need arises.

Desirable

• Demonstrated experience working cross-functionally and handling significant improvement initiatives (e.g., project management skills)
• Strong problem-solving skills
• Strong negotiating/influencing skills

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being bold - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, groundbreaking methods and bringing unexpected teams together.

So, what’s next!

Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

AstraZeneca is an equal opportunity employer.

AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or birthing parent leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Expectation of working in the office 3 days a week statement

When we put unexpected teams in the same room, we ignite daring thinking with the power to encourage life-changing medicines. In-person working give 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. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our outstanding and bold world!!!

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 authorisation and employment eligibility verification requirements.