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Quality & Regulatory Specialist

AT Henry Schein
Henry Schein

Quality & Regulatory Specialist

Chatham, United Kingdom

Job Description

We're looking for a diligent, detail focused, Quality & Regulatory Specialist to join our team here in Gillingham, Kent.

The role holder will be responsible for supporting the Quality & Regulatory team for the UK & Ireland, with the quality, regulatory and environmental processes and ensuring that the Quality Management System (QMS) and the Environmental Management System (EMS) are maintained and updated. As part of the role, this Team Schein Member will ensure that document controls are maintained, schedules, records and key processes are followed and help ensure overall compliance for our Business quality objectives.

You can read more about the main duties of this role below, as well as what we offer our Team Schein Members:

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Duties & Responsibilities:
  • To act as the document controller for UK & IE locations defined under the shared quality management system
  • Support the completion and publication of QMS & EMS standard operating procedures (SOPs) and work instructions (WI), ensuring that published documents are revision controlled, reviewed at defined intervals and relevant approvals are on file.
  • Maintain QMS/EMS schedules and their publication at current status; internal audit and external audit schedules, Technical Agreement and other continuous improvement lifecycle schedules.
  • Maintain, co-ordinate and follow up QMS/EMS registers and open actions for Risk Assessments, CAPAs, Deviations, Change Control and Environmental programs of work, ensuring any agreed submission/completion dates are pursued through to completion.
  • Take part in company process continual improvement initiatives, supporting in the documentation and follow-up of agreed actions.
  • Support the collation of data inputs required for the Management Review process as well as the follow up of 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.
  • Support the maintenance of the RAQA & EMS company intranet system, ensuring current versions of documentation is accessible to the Business.
  • This role is site based, at our Gillingham, Kent, head office, occasional home working may be possible with agreement.
  • Other tasks and projects as needed.

Qualifications & Experience
  • Good standard of secondary education.
  • Fluent in written and spoken English.
  • Experience in document control management, preferably within a quality or environmental management system.
  • Proficient in the use of the Microsoft Office Suite of tools, with intermediate level experience of Excel desired.
  • We would also like it if you had prior knowledge or experience of ISO9001 and/or ISO14001, but it's not essential.
  • Similarly, awareness of MDD93/42/EEC, and Good Distribution Practice requirements would also be desirable.

We think the type of person best suited to this role would be:
  • systematic and patient, in order to get the job done right first time
  • technically focused with a great attention to detail
  • a disciplined time manager, able to work through multiple priorities to deliver results
  • someone who can work independently whilst contributing to the success of a wider team
  • conscientious and hands-on in getting tasks completed to a high standard
  • an individual who likes to build trusted relationships with internal and external stakeholders based on knowledge and technical expertise
  • someone who likes to learn and apply their new skills

If the above sounds like you, we'd really like to hear from you.

In exchange, we're offering the right candidate:
  • A competitive basic salary
  • The opportunity to earn up to 10% annual bonus based on personal and business performance
  • 5% matched pension scheme with Scottish Widows
  • 25 days holiday, plus public holidays
  • Life assurance 4x basic salary
  • A variety of flexible health & wellbeing benefits
  • Paid time off annually to volunteer
  • The opportunity to study and gain a suitable professional qualification

Henry Schein is committed to the principle of equal opportunities in employment in all spheres of its operation. Henry Schein UK Holdings strives to operate a policy of equal opportunity and not discriminate against any person gender, race, colour, nationality, ethnic or national origin, religion, sexual orientation, marital status, disability, age or any other characteristic protected by law.

Client-provided location(s): Gillingham, UK
Job ID: Henry_Schein-R128047
Employment Type: Full Time