Senior Specialist - Quality Assurance (Night shift)
AstraZeneca
UK - MacclesfieldPosted Discovered via the company's careers siteMatch locked
Full time
Introduction to role
Are you ready to make a significant impact in the world of aseptic manufacturing and packing? The Senior Specialist - Quality Assurance is accountable for delivering QA leadership and oversight for aseptic manufacturing and packaging operations on the night shift. You will provide GMP and aseptic processing expertise, assure cleanroom compliance, influence operational decisions within the Process Execution Team (PET), and support timely and compliant product release. This role is pivotal in safeguarding patient safety, regulatory compliance, and value stream performance.
Accountabilities
•
Cleanroom and Aseptic Oversight
Provide technical guidance on cleanroom standards, aseptic techniques, and environmental controls aligned to current
EU GMP Annex 1
and internal procedures.
•
Deviation and CAPA Management
Advise on deviations, lead or contribute to root cause analysis, and agree
CAPAs
to prevent recurrence and improve process robustness.
•
Product Quality/Release Support
Support or perform product release activities as required, ensuring batch documentation, data integrity, and compliance.
•
GMP Training and Coaching
Complete required PET GMP training and coach manufacturing personnel on
cGMP
, aseptic behaviours, data integrity, and contamination control.
•
Compliance and Continuous Improvement
Proactively identify compliance risks and opportunities for business improvement, efficiency savings, and
lean
optimization.
•
Change Control
Lead or support local/cross-functional change controls ensuring validated state and regulatory alignment.
•
Quality Systems Execution
Contribute to
PQR
, quality risk management, metrics (e.g., deviations, CAPA effectiveness), and documentation updates.
Essential Skills/Experience
- Degree (or equivalent) in a scientific discipline (e.g., pharmacy, microbiology, chemistry, biochemistry, engineering). A clear, comprehensive grasp of the
quality assurance
function, along with a strong understanding of
other business functions
and how they work together to achieve
business objectives
in a
lean manufacturing
environment.
•
Quality Assurance in Pharmaceutical Manufacture
with strong understanding of cross-functional operations in a lean environment.
•
Aseptic Processing or Packing
knowledge, including cleanroom behaviours and contamination control principles.
•
Current GMP Knowledge
and working familiarity with
EU GMP Annex 1
,
ICH Q9/Q10
, and data integrity principles.
•
Communication and Influencing
skills with cultural awareness; ability to coach operators and technicians.
•
Decision-Making
within general operating guidelines using risk-based, science-led judgment.
•
Permanent Night Shift
availability.
Desirable Skills/Experience
•
Experience in Aseptic Manufacturing operations and sterile packaging lines.
•
Microbiology Experience
, including environmental monitoring, sterility assurance concepts, and interpretation of microbiological data.
•
Quality Risk Management
application (FMEA, HACCP).
At AstraZeneca, we are committed to quality that goes beyond compliance - driven by a proactive, science-based approach that prioritizes patient safety and product excellence. We foster an inclusive community where collaboration is key, allowing us to innovate and adapt swiftly. With a focus on growth and innovation, you'll find endless opportunities to develop your expertise and contribute to groundbreaking advancements in healthcare!
Ready to take on this exciting challenge? Apply now and be part of a team that makes a real difference!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Date Posted
30-Oct-2026
Closing Date
14-Nov-2026
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.
Not included in the source posting: about the role, what you'll do, benefits.
Skills
qa
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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