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Senior Specialist, Quality Assurance

4 weeks ago

Pennsylvania, United States AstraZeneca Full time
At AstraZeneca, you can be part of crafting the next phase of Operations' pathway towards the 2025 strategy. Build on our foundations of high performance through agility, responsiveness, reliability and efficiency to deliver our new modalities and complex pipeline to market at speed. Backed by an encouraging team, be part of accelerating our operational excellence with innovations in ground breaking science, Lean ways of working and evolving digital technologies.

Accountabilities:

Act as a local process owner/champion for Quality Operations processes:

External Audit Readiness - handle the preparation activities for internal and external inspections, including FDA, EMA, and other regulatory bodies. Develop and implement inspection readiness plans and conduct routine mock inspections to ensure preparedness. Actively participate in audits, inspections, and response process as applicable. Self Inspection Program - develop and drive the site's annual self inspection plan to ensure Quality standards are being met in advance of external regulatory audits. Batch Record Review/Approval - act as the final signatory on production records to ensure data integrity and right first time execution of the production records. Partner with operations teams to remediate errors and improve execution of production standards. Line Clearance and Oversight - conduct daily walk through inspections (GENBA) of the Aseptic Filling, Pack Operations, and supporting areas throughout the facility to confirm GMP processes and standards are followed. Validation Review/Approval - support real time review of validation activities and final approval of validation packages to ensure data integrity principles and quality by design. Work cross functionally with other Quality teams to support:

Acceptable Quality Limit (AQL) Inspections Deviation Investigations and CAPA Planning Quality Risk Management Product Complaint Investigations Change Control Planning and Execution GDP Data Review and Trending

Partner and support operations functions related to Quality standards and regulatory expectations.

Lead and facilitate cross-functional teams, providing support in risk management, compliance and sharing valuable observations and findings.

Lead and implement medium to high level simplification and improvement initiatives in collaboration with quality assurance colleagues.

Own and update training content and facilitate training sessions focused on quality standards, compliance, and inspection preparation for staff at various levels.

Stay continually updated with current industry practices and changes in regulatory guidelines to ensure the organization remains compliant.

Essential Skills/Experience: - Bachelor's degree in a Science / technical field such as Pharmacy, Biology, or Chemistry - 5 years' experience within pharmaceutical manufacturing and quality - Experience in business process/ quality system management. - Strong orientation for continuous improvement and process streamlining and optimization. - Experience applying Lean principles and driving change initiatives within a structured framework. - Experience with newer digital tools and technologies related to quality systems management. - Self-motivated individual that works independently. - Strong regulatory and compliance experience with an organization such as FDA, MHRA, EMA, ANVISA, HC, and KFDA. - Effective communication and interpersonal skills are required.

Desirable Skills/Experience: - Project management experience - Lean manufacturing experience

At AstraZeneca, we are breaking new ground every day. With constant new products and launches, there's never been a better time to join our team. We grow with innovation, continuously seeking new ways to deliver life-changing medicines to patients. Our collaborative culture encourages idea-sharing and problem-solving, fostering a positive space where everyone can contribute to our collective success. We are committed to doing things the right way with balanced lifecycle management, making a significant impact on the future of healthcare.

Ready to make a difference? Apply now to become part of our dynamic team

Date Posted 17-Feb-2025

Closing Date 02-Mar-2025Our 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. AstraZeneca