Hobson Prior is currently seeking a Senior Quality Compliance Specialist for one of the world’s largest healthcare companies. This client aims to improve access and affordability to pharmaceuticals enabling healthier communities worldwide. This is a great job opportunity working with a thriving client in which you will be responsible for ensuring all tasks are carried out in compliance with all regulations and quality operations.
- Accountable for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Guide Quality Operations / System and support staff to ensure appropriate control systems are in place to meet changing regulatory, corporate and industry standards
- Ensuring investigation of quality actions, internal and external audit observations are completed and have actions plans in place with appropriate effectiveness monitoring performed
- Recognise and implement Lean projects as appropriate to Compliance activities
- Manage internal audit schedule by agreeing annual requirements and provide support during external audits
- Perform internal audits to complete audit reports and effectiveness reviews.
- Manage the external audit inspection readiness program for the site
- Control the response process for all external audit commitments
- Produce monthly and quarterly quality reports for review by senior and executive management
- Generate required data for Dashboard monthly reviews
- Minimum of 3 years in the regulated industry.
- Expertise of quality systems and techniques including ISO 13485 and FDA QSRs
- Thorough knowledge of Good Manufacturing Practice
- ISO 13485 Lead auditor trained
- Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations
- Understanding of ISO9001, ISO13485 and FDA Quality System Regulations would be desirable
- Strong organisational skills with the ability to work self-sufficiently
- Computer literate
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focussed on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.