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Quality Assurance Officer posted by Etienne Associates Ltd

Newhall, Derbyshire
£25,000 - £35,000 / year
NHS Band 5

Job Description

A new role-based at a Pharmaceutical Manufacturer based in the East Midlands, looking for an ambitious Quality assurance individual to join their strong team.
Responsibilities / Accountabilities
Support the Quality Manager to ensure compliance and efficient operation of the Quality Management System and deputise for the Quality Manager in their absence.
Act as a subject matter expert within the following areas of functional expertise to ensure compliant and efficient operation of the following systems/processes:
Quality Management System
Document Management
Internal Audit process and program
Management Review – preparation of data/metrics
Quality process monitoring – oversight and maintenance of tracking systems for all quality-critical processes
Customer technical agreements
Data integrity – oversight and maintenance of site Data Integrity
Horizon Scanning
Site validation, calibration, and equipment maintenance
Equipment qualification and associated process validation
Cleaning validation & cross-contamination risk assessments
External audit management
Customer / third-party audits
Regulatory inspections
Supplier Management
Supplier selection, qualification, and auditing
Supplier performance reviews
Act as a lead auditor for internal and external audits.
* Promote a culture of continual improvement within the team and wider company by:
* Championing root cause analysis and the use of appropriate risk management tools throughout all activities.
* Coaching others to help them understand how their day-to-day activities related to the Quality Policy and Quality Objectives.
* Ensuring that all processes and working practices within your area of responsibility are constantly reviewed and any compliance or efficiency improvements are implemented in a timely fashion proportional to the risks identified.
* Ensure all procedures relating to the systems you are responsible for are kept up-to-date and reflect both internal and external best practices.
* Act as a peer-reviewed to check and approve work generated within your own and the wider quality team.
* Ensure any corrections or errors are fed back to the author of the work in a constructive manner to prevent reoccurrence.
* Support and develop other members of the Quality Assurance team by:
* Ensuring adherence to Health and Safety, Good Manufacturing Practice, and other relevant guidelines and legal obligations.
* Ensuring all team members are adequately trained and supported in the performance of their duties and responsibilities.
* Coaching team members to understand their own performance and how it relates to company performance and their own career development.
* Supporting other members of the team to ensure their goals and performance targets are met.
* Supporting team members to develop their skills and functional expertise.
* Support the wider Quality function by:
* Ensuring adherence to Health and Safety, Good Manufacturing Practice, and other relevant guidelines and legal obligations.
* Supporting team members to develop their skills and functional expertise.
* Ensure delivery of activities within your area of responsibility to ensure customer and business targets are met.
Key Capabilities
Excellent attention to detail,
Analytical and problem-solving abilities,
Detailed knowledge of root cause analysis and risk management tools and their application,
Good understanding of applicable regulations, standards, and best practices,
Good communication, interpersonal and influencing skills,
Good numerical skills and the ability to handle and analyse data,
Sound knowledge of data analysis tools (e.g. Excel, Minitab, etc.),
The ability to present complex information (both internally and externally) to diverse audiences and levels of understanding,
Planning and project management skills.
Key Performance Indicators
All Quality Objectives are consistently met for all processes and systems within your area of responsibility,
Rapid and appropriate corrective actions taken to address any drift from Quality Objective targets,
Evidence of evolution of processes to meet current best practices and increase efficiency.
The individual workload is managed to ensure customer and business targets are met and any inability to meet targets is clearly communicated as soon as the problem is recognised,
No avoidable or repeat incidents/deviations are associated with processes and systems within your area of responsibility.
Processes are operated to meet business and customer expectations and targets

Reference Number


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