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):