Quality & Regulatory Associate

Job Description

Responsible to support the quality, regulatory and environmental processes for Henry Schein UK & Ireland, ensuring the Quality Management System (QMS) and Environmental Management System (EMS) document controls are maintained, and the completion and update of schedules and records from key processes are pursed through to completion and maintained in the company systems. Taking active part in continuous improvement initiatives and business quality objectives as assigned.

This role is suited to candidates with 2-3 years’ proven experience in quality systems within the pharmaceutical or medical device sectors. Candidates should have a sound understanding of regulatory compliance, strong attention to detail, and the ability to consult effectively with internal teams and regulatory authorities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· To act as the document controller for UK & IE locations defined under the 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 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, authorisations, and records are on file.

· Support the coordination, maintenance, and update of Training procedures.

· Support the development of the QARA & EMS company intranet system, ensuring current versions of documentation are accessible to the business.

· Other tasks and projects as needed.

Physical Activities

Job holder based at the Henry Schein UK Holdings Ltd, Gillingham office.

Occasional UK/IE inter site visits.

Job Skills & Experience Required:

Experience:

- 2-3 years’ experience in a Quality and/or Regulatory role.

- Regulatory Affairs and Quality System and or Environmental Management experience.

- Knowledgeable in Good Distribution Practice (GDP).

- Awareness of ISO 9001 and/or ISO 14001 quality/environmental management systems.

- Awareness of MDD 93/42/EEC, Good Distribution Practice requirements 2013/C 343/01.

Qualifications:

- Batchelor’s degree in Regulatory Affairs, Life Sciences/Environmental Sciences, or related field.

- Or demonstratable knowledge of medical/pharmacy industry.

Specialised Knowledge and Skills:

- Document control for Quality/Environmental Management Systems.

- Proficient in the use of Microsoft Office.

- Advanced level use of Excel.

- Ability to manage and meet deadlines.

Other:

- High level accuracy/attention to detail.

- Demonstrates advanced oral and written communication skills.

- Must be fluent in written and spoken English.

- Ability to operate as part of a team.

- Ability to build and maintain effective relationships internally and externally.

- Excellent time management skills.

- Ability to drive actions through to completion.

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.