Senior Specialist - Quality Assurance (Night shift)

AstraZeneca; Macclesfield; On-site; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Senior Specialist in Quality Assurance to join their dynamic team. This pivotal role involves ensuring compliance with regulatory standards in aseptic manufacturing and packaging. You will provide technical guidance, oversee clean room operations, and influence decisions that enhance efficiency and quality. The company fosters a collaborative environment, prioritizing patient safety and product excellence. With a commitment to professional development and innovation, this position offers a unique opportunity to make a significant impact in healthcare. If you're ready for a challenge, apply now and contribute to groundbreaking advancements!

Qualifications

• Degree level in a scientific discipline and experience in a GMP environment.
• Strong understanding of quality assurance and lean manufacturing.

Responsibilities

• Provide QA expertise to ensure compliance with regulatory standards.
• Oversee clean room operations and manage audits and inspections.
• Identify opportunities for business improvement and efficiency.

Skills

GMP Compliance

Aseptic Packaging Knowledge

Communication Skills

Problem Solving

Education

Degree in Scientific Discipline

Job description

Job Title: Senior Specialist – Quality Assurance (Nights)

Location: Macclesfield

Competitive salary and benefits

Introduction to role:

Are you ready to make a significant impact in the world of aseptic manufacturing and packing? As a Senior Specialist, you'll provide QA expertise and support to ensure that our processes meet all regulatory and AstraZeneca standards. Your role will be pivotal in overseeing clean room operations, maintaining compliance, and influencing decisions that directly affect our value stream. You'll work alongside manufacturing teams on Night Shifts within the Process Execution Team (PET) you support.

Accountabilities:

• Offer technical guidance on clean room standards, aseptic practices, and associated cGMPs.
• Advise on deviations and contribute to their resolution.
• Potential to perform product release activities.
• Complete GMP training within the PET.
• Maintain ongoing personal professional development.
• Promote safety, health, and environment standards.
• Ensure compliance with internal and external regulations.
• Proactively identify opportunities for business improvement and efficiency savings.
• Manage local/cross-functional change.
• Ensure plant readiness for audits and inspections.
• Contribute to the PQR process.

Essential Skills/Experience:

• Degree level or equivalent in a scientific discipline and experience of working in a GMP environment. A comprehensive understanding of own quality assurance function, as well as a strong understanding of other functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment.
• There is a requirement to work night shifts in this role permanently
• Knowledge of aseptic packaging.
• Ability to make judgements, within general operating guidelines.
• Competent to professional knowledge of current GMP requirements and regulatory processes.
• Good communication and influencing skills including cultural awareness.

Desirable Skills/Experience:

• Experience of working in aseptic manufacturing.

At AstraZeneca, we are driven by a commitment to quality that goes beyond compliance. Our proactive, science-based approach empowers us to make decisions that prioritize 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

06-May-2025

Closing Date

19-May-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.