
Senior Quality Assurance Specialist
2 days ago
Reporting to the Quality Director, we are seeking a talented Quality Assurance Specialist to support the management and oversight of QMS processes in our virtual organisation, Recipharm AB. This is a hybrid role with possibilities to work from home as well as from our office in Sweden (Stockholm HQ) or the UK (office located in Cheadle).
Main Tasks & Responsibilities:
- Manage and lead GxP Training, perform SOP training and lead training in the eQMS.
- Track KPIs for deviations, change controls, CAPAs, change control actions, effectiveness checks, complaints and training to ensure the organisation meets the Global Quality requirements.
- Perform GAP Analysis of the organisation's SOPs to global SOPs.
- Responsible for the creation, maintenance and archiving of GxP documentation, including but not limited to, SOPs, Quality Agreements, training, deviations, change controls, CAPAs, effectiveness checks, complaints, and PQRs.
- Provide support during MHRA/Health Authority inspections, customer audits and internal audits.
- Degree in Quality Management, life sciences or a related field.
- Knowledge of GMP and GDP.
- Detailed knowledge in Good Documentation Practice and Data integrity.
- Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy.
- Competent knowledge of risk-based approach, used in deviations and risk assessments.
- Effective planning and time management, organisational.
- Ability to build relationships with key internal and external customers.
- Proven experience of working to meet high standards and provide excellent customer service.
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