Quality Assurance Associate

Type: Permanent

Location: Macclesfield UK

Competitive salary and benefits

AstraZeneca is a global, science-led, patient-focused biopharmaceutical 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.

As a hard-working team, we are united and motivated by our shared purpose – to push the boundaries of science to deliver life-changing medicines. We come to work each day to make a difference – to patients, society, and our company.

Here you will experience a fast paced and agile environment as we continue to support the business on a journey of evolution and growth, driven by new, exciting technology and digital innovations. It’s challenging and sometimes demanding, and that’s why we love it.

Job Description

Experienced Quality Professional, with a high level of technical process understanding, across a range of manufacturing areas including tablet formulation, aseptic manufacture and packing; with particular focus on the development and management of Pharmaceutical Quality Systems (PQS) in line with AZ’s global policies and procedures.

The Quality Assurance Associate (QAA) will act as Business Process Owner (BPO) and primary point of contact for all QA matters related to the support of the Site Quality Systems. Reporting to the head of the QMS team the QAA will take direct accountability for a number of key Quality Systems; including taking control of major quality issues and implementing good process management to ensure efficient, effective & transparent ways of working. The QAA will ensure effective execution at site level as well as influencing the development and application of new and changing regulations at global level.

Responsiblies

The QAA will adhere to all key policies/ procedures and also the Manager Accountability Framework if the role holder manages people.

The QAA (QMS) Key Accountabilities include:

• Leads definition & design of the key QMS processes to agreed strategic direction and in line with AZ Global Policies

• Document the process ensuring the relevant supporting SOPs are in place and are in line with AZ Global Procedures

• Apply Process Governance for the process:

  • Establish Process Network for the process

  • Accountable for communication, roll out and training of process

  • Accountable for continuous improvements through the agreed Process Network

  • Own process important metrics and reporting

• Perform Process Self-Inspections

• Manage relationships with key partners

• Work with key partners to ensure process adherence

• Work with Ops IT regarding System Governance

• Perform Process Maturity Assessment and strive to constantly improve the PQS

• Own Business Continuity Plan for the process

• Represent the Site at Regional and Global Process Team Meetings

• Provide support for internal and external inspection preparations as well as significant audits (both internal and external) to aid in developing improvement plans. Follow up any actions relating to QMS to ensure ongoing compliance.

• Provide expert advice on Good Manufacturing Practice, with reference to current guidelines and regulations.

Typical Accountabilities:

Safety, Health and Environment

Promoting an environment of no hurt, harm or alarm

• Work in a manner which promotes the safety and well being of self, others and environment

• Contribute to improving SHE performance, proactively use STOP cards to identify SHE hazards and take appropriate actions

GMP / Compliance and Ethical Conduct

Ensuring compliance of self and others to internal and external regulations

• Align with all systems, processes and procedures in line with statutory/ legislative / quality requirements

• Conduct activities and interactions consistent with Things we value and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.

In addition, for Managers and Project Team Leaders:

• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness.

• Leaders with accountability for GXP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

• Optimising performance outcomes of self/direct reports and ensuring understanding of contribution.

Delivery / Supply

• Ensuring customer service is always considered.

Cost

• Promoting a cost conscious environment to enable effective cost management.

Lean & Agile Culture / Standardised ways of working

• Ensure all work is carried out in accordance to approved and established processes and procedures.

Essentials

• Prior experience in Good Manufacturing Practice, with comprehensive knowledge of international GMP requirements /quality systems and Pharmaceutical manufacturing/packing and testing technologies.

• High level of technical process understanding across a range of manufacturing areas.

• Comprehensive knowledge of and application of cGMP requirements of Quality Management Systems.

• Comprehensive working knowledge of regulatory interactions and compliance procedures and ability to apply this in an operations environment.

• Management of a complex and changing workload.

• High level of customer focus and strong ability to reinforce and maintain quality standards.

• Strong influencing and negotiating skills across all levels of the organisation.

Desirables

• Eligible/ Trainee QP

• Degree or equivalent experience or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry, Biology or Engineering.

• International /Multiple Site or Multi functional experience.

• Experience of working in a Lean environment, and knowledge of Lean principles and tools would be of benefit, but not essential.

Hybrid working

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire 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 unique and ambitious world.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and spark your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

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

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours

Where can I find out more?

Our Social Media,

• Follow AstraZeneca on LinkedIn - LinkedIn

• Follow AstraZeneca on Facebook - Facebook

• Follow AstraZeneca on Instagram - Instagram

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.