Salary - c£28,000

Shift - 8:30 til 17:00

To provide effective Quality Assurance support in line with the Good Distribution Practice (GDP), ISO 9001, and ISO 13485 operations of the UK business to ensure compliance for our clients, all external bodies, and our own internal standards.

Your Tasks

• Work closely with the Quality Managers, customers, and stakeholders to ensure that compliance with the regulations are upheld.
• Day-to-day management of the quality system to ensure compliance against GDP, ISO 9001, and ISO 13485 requirements.
• Provide Quality Assurance (QA) support to initiate, engage, and escalate critical and major compliance issues through QMS processes, including deviations, CAPAs, and change control.
• Manage and monitor the KPIs for the business, identifying trend areas and communicating with key stakeholders to drive improvement.
• Co-ordinate audits in preparing and participating in hosting both internal and external audits with customers and regulatory authorities.
• Support the maintenance of the annual supplier evaluation schedule to ensure compliance with process and QMS.
• Support client onboarding and project implementations ensuring compliance with QMS activities including validation.
• Liaise with suppliers to ensure compliance with GDP (good distribution practices) activities and maintenance of GxP systems.
• Support the ongoing compliance with the Arvato Global Quality System, report KPIs to GLO QA team, and attend monthly/quarterly meetings when required
• Train and provide assistance to business functions on quality procedures, protocols, and documentation

Your Profile

Someone who is organized, methodical, and can prioritise a busy workload and who can liaise with stakeholders and customers of all levels.

You will have experience in:

• quality assurance
• Reviewing and updating SOPS, working instructions, and quality agreements for customers and suppliers.
• and supporting QMS activities; Investigations, complaint management, gathering change control evidence, audit readiness, compiling KPIs, track completion to SLA
• and/or knowledge of Good Distribution Practice (GDP), ISO 9001, and ISO 13485  and systems such as SAP, electronic QMS, and temperature monitoring portals
• and competent with Office applications (Word, Excel, Visio, Projects etc)

Previous quality assurance experience in Healthcare, medical devices/pharmaceuticals would be an advantage, but not essential

.

What do we offer?

22 days annual leave with the option to purchase up to an additional 5 days.

Pension contribution

A life assurance policy that pays out 4 x Salary

Employee Assistance Programme that provides you with confidential support, information, and advice to help you.

Employee Discount Scheme through Treats

Free car parking