Специалист по обеспечению качества

Typical Accountabilities:
• Provide expert advice on Good Manufacturing Practice/Good Development Practice/ Good Laboratory Practice to Operations and ensure compliance with the associated quality standards

• Advise on deviations and use judgement to approve or reject product within tight business deadlines

• Perform product release activities and recommend batch disposition to the Qualified Person

• Collate the required documentation for product quality reviews within the required timescales

• Ensure compliance with change management processes within the Process Execution Team and approval of associated documentation at a local level

• Approve and respond to local complaint investigations, identify and rectify any trends

• Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgements, within general operating guidelines

• Look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance

• Produce and deliver Good Manufacturing Practice training within the Process Execution Team

• Drive out any non value adding activities and support lean operations and support line management to develop a culture of continuous improvement

• Ensure plant readiness for any regulatory inspections

• Plan and lead local audits (both internal and external) to aid in developing follow up improvement plans to ensure ongoing compliance


Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - 0


What is the global remit? (how many countries will the role operate in?):
• Own country

Education, Qualifications, Skills and Experience:
• Essential: Qualified to degree level/or equivalent in a scientific discipline; Experience in a Good Manufacturing Practice environment; Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice/Good Laboratory Practice
• Desirable: Eligible Qualified Person

Key Relationship to reach solutions:
• Internal (to AZ or team): Process Execution Team; Manufacturing; Quality Assurance
• External (to AZ):

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.