Quality & Regulatory Associate

Henry Schein, Inc.; Gillingham; Sur place; GBP 30 000 - 42 000; Plein temps

Résumé du poste

Henry Schein UK Holdings Ltd is seeking a quality/regulatory document controller for the UK & Ireland. Based at the Gillingham office, you will manage QMS/EMS document control, support SOPs, records, and audit schedules while driving continuous improvement.

You will have 2–3 years of quality systems experience in pharma/medical devices, with GDP and ISO awareness, and strong English communication to collaborate with internal teams and regulatory authorities.

Qualifications

• 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.
• Fluent in written and spoken English.

Responsabilités

• Act as the document controller for UK & IE locations under the QMS.
• Publish and revise QMS/EMS SOPs and WI with proper approvals.
• Maintain QMS/EMS schedules, audit schedules, and records.
• Coordinate risk assessments, CAPAs, deviations and environmental programs.
• Support continual improvement initiatives and Management Review data.
• Assist in filing systems and training procedure updates.
• Help develop QARA & EMS intranet documentation access.

Connaissances

Quality systems

Regulatory affairs

GDP knowledge

ISO 9001/ISO 14001 awareness

Formation

Bachelor's in Regulatory Affairs / Life Sciences

Outils

Microsoft Office

Excel

Description du poste

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. Over 90 years ago Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the Great Depression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners. Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company. Now serving more than 1 million customers in 33 countries and territories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes. We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our Team Schein Values as our founders would have wanted. We live those values by ensuring that our culture focuses on the wellness of our team, which we accomplish by providing a safe space for individuals to develop and contribute authentically, with opportunities to give back to society and the communities where we live and work. No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.

Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of www.henryschein.com/careers, as a result of a physical or mental impairment, you can request reasonable accommodations. Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.

US Candidates: [e-mail] UK and Ireland Candidates: [e-mail] Australia and New Zealand Candidates: [e-mail] Malaysia Candidates: [e-mail] Italy Candidates: [e-mail]

It is important to us to offer different types of work arrangements. Please see the types we offer below.

• Work From Home: Work is performed directly from the TSM's home office.
• Hybrid: Time is scheduled between working from a TSM home office and at a company facility, as required.
• Onsite: Work is performed exclusively at a company facility.
• Field: Position requires traveling to different locations within a specific geographic territory, as assigned.