QA Validation AssistantBirminghamSalary dependant on experienceA global medical diagnostic company is looking for a new QA Assistant to assist with performance qualification/ process validation trails....
Competitive salary & package
Do you have QA experience? Have you got experience of managing a small team?
- Lead the Quality Assurance team to ensure compliant and efficient operation of the following systems/processes:
- Quality Management System
- Document Control
- Corrective/Preventative Action system
- Internal Audit process and program (including mock recalls)
- Management Review - preparation of data / metrics
- Quality process monitoring - oversight and maintenance of tracking systems for all quality-critical processes
- Customer technical agreements
- Annual Product Quality Reviews
- Data integrity - oversight and maintenance of site Data Integrity Log and associated risk assessments
- Horizon Scanning*Site validation, calibration and equipment maintenance
- Equipment qualification and associated process validation
- Cleaning validation & cross-contamination risk assessments
- Management of the site Validation Master Plan
- Bulk, clean and dirty hold time validation
- Site pest control program
- External audit management
- Customer / third-party audits
- Regulatory inspections
- Management of samples for regulatory surveillance
- Supplier Management
- API declarations & excipient risk assessments
- Supplier selection, qualification and auditing
- Supplier performance reviews
- Supply Chain mapping
- Control of transportation suppliers
- Promote a culture of continual improvement within the team and wider company by:
- Championing root cause analysis and use of appropriate risk management tools throughout all activities.
- Coaching others to help them understand how their day-to-day activities relate 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.
- Lead and develop your team by:
- Ensuring adherence of both you and your team 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.
- Managing individual and team contributions to ensure goals and performance targets are met.
- Supporting team members to develop their skills and functional expertise.
- Act as a subject matter expert within your area(s) of functional expertise both for your team and the wider organisation.
- Ensure the customer's expectations (both implicit and explicit) are embedded throughout all activities.
- The ability to lead, motivate and manage a team,
- 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.
If you're interested in the role, please make an application online or alternatively contact me on 0121 728 8455 should you have any questions.