Job Description
Quality & Regulatory Specialist
BioTalent are delighted to present this opportunity to join a leading provider of healthcare products with a global presence in over 30 countries worldwide.
The Quality & Regulatory Specialist will be responsible for supporting the Quality & Regulatory team, ensuring that the Quality Management System (QMS) and the Environmental Management System (EMS) are maintained and updated. You will will ensure that document controls are maintained, schedules, records and key processes are followed and help ensure overall compliance.
Duties & Responsibilities
* Act as the document controller under the QMS.
* Support the completion and publication of QMS & EMS standard operating procedures (SOPs) and work instructions (WI).
* Maintain QMS/EMS schedules and their publication at current status; internal audit and external audit schedules, Technical Agreement and other continuous improvement lifecycle schedules.
* Open actions for Risk Assessments, CAPAs, Deviations, Change Control and Environmental programs and ensure any agreed submission/completion dates are pursued through to completion.
* Support continuous improvement initiatives.
* Support the collation of data inputs required for the Management Review process and follow up on agreed open actions.
* Support the electronic and manual filing systems ensuring access availability of current certificates, authorization’s, and records are on file.
* Support the coordination, maintenance and update of Training Matrices.
Qualifications & Experience
* Educated in a science or related background.
* 3-5 years’ industry experience.
* Knowledge of ISO 13485 and ISO 9001 are a distinct advantage.
* Experience preparing/participating in internal audits, agenda settings etc.
* Background in pharmaceuticals or medical devices preferred.
Shortlisting for this position has begun with a view to holding interviews over the next week. For further information please contact Anita Osibuamhe at BioTalent on +44 20 3862 2742 for a confidential conversation or apply now!