Senior Specialist Quality Assurance - Environmental Assurance (18 Month Secondment / Fixed Term Cont

Introduction to role

Are you passionate about ensuring the highest standards in manufacturing processes? As a Senior Specialist Quality Assurance - Environmental Assurance, you will provide microbiological QA expertise and support for manufacturing. You will ensure that manufacturing processes and operational controls meet aseptic requirements and conform to the critical control strategy. Overseeing aseptic and clean room operations, you will ensure particle, physical, and microbiological environmental control in production and/or QC testing facilities. Your role directly impacts the value stream by influencing clean room decisions through expert advice, ensuring compliance with current regulations.

Accountabilities

• Ensure an effective microbiological, particle, and physical monitoring programme is established and maintained.
• Provide technical advice on clean room standards, aseptic behaviours, and their impact on procedures/manufacture in line with the Critical Control Strategy.
• Assist in major failure investigations, ensuring recommendations for product disposition are made and documented.
• Maintain and develop your professional capability.
• Provide training and coaching to personnel.
• Act as a key user of EQV; ECMS author, approver, and deviation manager for deviations/environmental excursions.
• Conduct self-inspections and observations.
• Perform Environmental reviews to support batch release.
• Manage change control.
• Proactively seek opportunities to improve environmental compliance by suggesting improvements to monitoring programmes and procedures.
• Manage local and cross-functional change.
• Ensure high aseptic standards are maintained in production and/or QC testing in clean rooms.
• Participate in regulatory and internal audits and inspections.
• Contribute to the preparation of regulatory submissions/PQR process.

Essential Skills/Experience

• Scientific degree, ideally in biology/microbiology or equivalent experience in industry
• Significant experience in a GMP environment, with a strong understanding of aseptic manufacturing
• Essential Functional Capability at the Professional level- Aseptic Manufacture and Environmental Control.
• Knowledge of Current GMP requirements related to their Technical expertise and of regulatory processes.
• Knowledge of microbiological and physical environmental monitoring.

Desirable Skills/Experience

• Experience (or equivalent) in the Environmental Assurance Office role.
• Good communication and influencing skills including cultural awareness.
• Understands own leadership styles, capabilities & their impact on the team.
• There may be a requirement to work shifts in this role as required by the business.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work five 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 unique and ambitious world.

At AstraZeneca, our work is important and valued. We are at the forefront of innovation, constantly trialling the latest models and technologies to improve reliability and excellence in our processes. Our commitment to quality ensures that every batch we certify meets the highest standards, making a real difference to patients' lives. With a focus on growth and innovation, there are always exciting opportunities to develop your career.

Ready to make an impact? Apply now to join our team!

Date Posted

05-Feb-2025

Closing Date

12-Feb-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.