Quality Officer – London

Job title:

Quality Officer – London

Company

Aspen Pharma Group

Job description

What we look for in candidatesAt Aspen, our culture is built on core values that drive our success and foster a supportive, innovative environment. We value Teamwork, where diverse perspectives and skills come together to enhance creativity and problem-solving. Innovation is at our core, as we continually seek better ways to achieve our goals and remain at the forefront of our industry. We demonstrate Commitment by exceeding expectations and building long-term relationships, while always striving for Excellence in everything we do. Our foundation of Integrity ensures that honesty, ethical behavior, and accountability guide our decisions. By proceeding with this job application, we understand that you share these values, and we look forward to reviewing your application and engaging with you further.The purpose of this role is:

• To ensure Aspen UK operations are in compliance with UK & Aspen Europe QMS and to ensure Aspen products are supplied in accordance with GDP & GMP.
• To ensure product storage and shipments are managed in compliance with GDP requirements and applicable Aspen procedures.

Position supports Logistics, Customer Operations and Commercial Distribution functions and is one of the QA technical contact points with Logistic Service Providers and Aspen region offices.Job Duties:Documentation & Quality Management System

• Management of UK Quality Documentation and coordination of the document control system
• Assisting in maintenance of training system, processes and procedures
• Generating and maintaining Quality Technical Agreements with Logistic Service Providers and Distributor Customers

Quality Assurance

• Monitoring and completion of deviations, complaints, CAPA and change controls to maintain compliance in partnership with other departments
• Carries out risk assessments for deviations, change controls and other GxP relation actions
• Develop proactive recommendations and participate in process improvement projects
• Perform, contribute to and coordinate audits and audit reports
• Prepare for and participate in internal and external inspection
• Assist in batch checks for product imported into the UK (delegated responsibility)
• Support the preparation of Health Authorities inspections and provide support for regulatory submissions
• Monitor sales order patterns for controlled drugs
• Completion of customer questionnaires
• Manage customer bonafide checks
• Produce KPI metrics for Quality Management Review

Regulatory Submissions

• Assist facilitation of batch specific variations at LSP
• Notify and liaise with health authorities on out of stocks and waivers
• Proactively participate in Performance management process to ensure delivery of own and team objectives
• Assist in tasks associated with maintenance of marketing authorisations as and when required
• Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times
• Ensure that accurate records are kept and maintained in a secure manner as per Good Documentation Practice; ensure proper data management and archiving

Logistic Service Provider (LSP) Coordination

• Be the primary point of contact for a number of LSP for the coordination of GDP activities and issues
• Develops a good working relationship with the LSP
• Assists in the preparation of KPIs and audits
• Preparation and control of QTAs

·Assess temperature excursions and returns escalated by LSP and provide corresponding quality decision on product.

• Compile update for Quality Systems Management Review (QSMR) meetings
• Monitoring and reporting on regular basis the status of regulatory submissions across the region

Any other duties as assigned by Senior Management

• High level education such as BSc in Life sciences or related area, a MSc and PhD is desirable
• Previous understanding of quality assurance, risk assessment and regulatory compliance
• At least 2-3 years in a similar role in Regulatory in the pharmaceutical or related industry
• Proficient English skills

Expected salary

Location

London

Job date

Wed, 02 Apr 2025 07:51:30 GMT

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