Reporting to the Quality Director, the QA Specialist supports management and oversight of the QMS processes in RPH Pharmaceuticals, a virtual organisation focusing on Intellectual property, with staff across 7 countries with a wholly owned subsidiary RPH Pharma Ltd (RPPL).
MAIN TASKS & RESPONSIBILITIES
RPH Pharmaceuticals currently integrates a new quality system and is now looking for a QA Specialist to support this integration process on a 6 months fixed term contract. Furthermore, the QA Specialist manage, maintain and support the eQMS. As required entering quality related issues into the eQMS and track that actions and tasks are completed on time and escalate any overdue records to Quality Director.
The role includes:
1. Manage and lead GxP Training, perform SOP training and lead training in the eQMS.
2. Tracking KPIs for deviations, change controls, CAPAs, change control actions, effectiveness checks, complaints and training to ensure the organisation meets the Global Quality requirements.
3. Perform GAP Analysis of the organisation’s SOPs to global SOPs.
4. 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.
5. Provide support during MHRA/Health Authority inspections, customer audits and internal audits.
6. Support QA team in Continuous improvements work, such as achieving goals/targets, proposing new ideas to improve/influence Site and Quality performance, efficiency and compliance.
SKILLS AND EXPERIENCE
ESSENTIAL
1. Degree in Quality Management, life sciences or a related field.
2. Knowledge of GMP and GDP.
3. Detailed knowledge in Good Documentation Practice and Data integrity.
4. Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy.
5. Competent knowledge of risk-based approach, used in deviations and risk assessments.
6. Effective planning and time management, organisational.
7. Ability to build relationships with key internal and external customers.
8. Proven experience of working to meet high standards and provide excellent customer service.
9. IT literate: Microsoft Outlook, Word, Excel, eQMS.
DESIRABLE
1. Understanding of GPvP.
WHAT WE OFFER/EMPLOYEE BENEFITS
Our core values of Respect, Reliability, Collaboration and Excellence shape every aspect of our work and our interactions with all our stakeholders. We seek individuals who are respectful, considerate and honest, value diversity and show integrity in their daily work. Our culture thrives on reliability, ensuring we consistently deliver on our promises and meet the expectations of our stakeholders through operational excellence. We believe in the power of collaboration, fostering an agile environment through teamwork and active listening. Our relentless pursuit of excellence drives us to deliver high-quality products and services, while maintaining a supportive and inclusive atmosphere where every team member is recognised and valued. Join us to be part of a community that is committed to mutual success and high standards.
LOCATION
This is a hybrid role with possibilities to work from home as well from an office in Sweden (Stockholm HQ) or UK (office located in Cheadle).
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