Quality Assurance Manager, CAPA
Bionical Emas - the Company
Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, delivering a unique, seamless approach to bring life-changing medicines to patients around the world.
With clients, staff and offices around the globe, we offer a varied and international experience.
Our clients range from smaller biotech’s to large global pharmaceutical companies, all with different needs and expectations. As a business, we have invested heavily in ensuring we have the systems, processes, and people, to deliver for the very varied requirements of our clients. The culture of Bionical Emas is friendly, flexible and supportive, where all staff are encouraged to grow, develop and exceed their expectations.
- Drives the integration and roll-out of the electronic QMS across the Group including audit scheduling, quality event management and document/training management modules
- Liaises and trains key Stakeholders to support understanding and compliance required to use the eQMS,
- Drives education of the principles for Quality Event Management from identification to CAPA effectiveness aligning with eQMS across the Group
- Develops training materials including quizzes and performs the role of the trainer
- Supports the maintenance of Policies, SOPs, Work Instructions, Quality Manuals, forms and templates and any other documentation that supports the Quality Management System (QMS) or a Clients QMS
- Inserts items into SOP Improvement and SOP Development Logs
- Analyse metrics concerning the function of the QMS such as data concerning Audits, SOPs, Training, Quality Events and CAPAs
- Actively manage and support stakeholders in their management of Quality Events, suspected fraud, misconduct and GXP breaches, data breaches, complaints and issues; ensuring all are fully investigated, documented, resolved and tracked
- Proactively manages CAPAs ensuring follow up until closure and effectiveness checks performed; ensuring all are fully documented, evidence obtained and tracked
- Assist preparation for hosting audits and inspections; checking of and supply of documents and files, arranging meetings
- Actively manages responses to audits and inspections; liaising with and supporting Business Process Owners and Stakeholders in their development of responses and CAPA
- Actively manages responses to quality questionnaires; liaising with and supporting Business Process Owners and Stakeholders
- Engage in activities across the Quality Assurance department and any other reasonable task approved by your Line Manager
Key things we are looking for:
- Education to graduate level in a science discipline, nursing or equivalent, or substantial relevant experience in a Clinical Research/PVG/GMP/GDP or QA environment
Capabilities / Experience
- Preferably previous Pharmaceutical Industry experience. Requires a thorough knowledge of the drug development process, an understanding of GxP regulatory compliance requirements, sound research and development practices, scientific and quality terminology, and quality evaluation techniques
- Strong influencer and trainer of people
- Sound knowledge of Quality Event and CAPA Management
- Competent technical writer
- Strong organiser and project leadership skills
- Strong understanding of process improvement, and delivering change management through known methodologies such as SixSigma/Lean
- Strong communication skills as verbal, written and presentation
- Highly committed to a culture of quality
Make a difference
At Bionical Emas, we are committed to supporting our clients and our staff, so that they can bring life-changing medicines to patients around the world. Join Bionical Emas on our mission to make a difference.