Quality Specialist Lead

QMS Management

• Ensures relevant regulatory information is available for product release
• Liaising with local and external affiliates to ensure regulatory compliance at manufacturing sites is maintained.
• Initiates, authors, and possibly assist in approvals of Deviations, ensuring they contain the essential elements necessary to assure continuous product and process compliance.  Assures completeness in terms of root cause, action taken, and preventative measures
• Authors, tracks, and/or ensures timely closure of commitments (Regulatory Agency, Investigation, Audit, PQR, and other)
• Provides oversight and support for Product Quality Complaints
• Authors and ensures timely completion of Change Controls, Change Assessments and Change Actions Generating and maintaining Quality Technical Agreements with Aspen Vendors, including periodic reviews.
• Vendor Management of all Aspen GxP Vendors
• Performs internal and external audits and self-inspections
• Ensuring Documentation for the different QMS processes are up to date and periodic reviews completed.
• Ensuring training is effective and objective of the training are met.
• Organising and hosting cross-functional calls between teams, markets & departments to progress Quality issues.

Monitoring Trends and Identifying Process Improvement Opportunities

• • Active participation in QSMR including generation and review of slides and hosting in the absence of the QMS manager.
    •  
      Team Lead Oversight
      Leading a team located in multiple locations, that consists of several Quality personnel and support the management: 
      
    • Assigning, coordinating and reviewing of performance for day-to-day tasks allocated to the team 
    • Determines priorities, timetables and assigns resources and tasks and is accountable for results 
    • Preparation of the regular reports regarding the assigned tasks/procedures progress 
    • Monitor operations to ensure compliance with department requirements and KPIs 
    • Assessing the team training needs and preparing the training programmes while minimising cost and downtime

Any other duties as assigned by your Line Manager

• Results and performance driven – deliver results that meet or exceed expectations
• Sense of urgency – responding to issues and opportunities in a timely manner
• Take ownership and accountability for activities
• Positive and pro-active approach to business tasks
• Ability to lead and support several concurrent projects/products and develop strong relationship within cross-functional teams.
• Be able to work autonomously and have good problem solving skills.
• Highly driven with enthusiasm to meet role requirements and to cope under demanding pressure
• Ability to prioritise decisions and activities to ensure efficient use of resources
• Ability to influence and partner with cross-site teams in a global pharmaceutical organisation
• Ability to work in environments with continuous change and ambiguity.
• Ability to collaborate online with management in different locations and time zones.

• Experience with and a fundamental understanding of European GMP /MAH
• Proficient in Ms Office, especially Word, Excel, PowerPoint, SharePoint and Teams

Occasional travel is part of the job

• honours Degree - BSc in Science