Quality Officer

Arvato; East Midlands; On-site; GBP 38,000 - 46,000; Full time

Benefits offered by this job

25 days annual leave

Pension

Life assurance 4x Salary

Employee Assistance Programme

Employee Discount Scheme

Free Parking

Job summary

Arvato is seeking a Quality Assurance support professional in the East Midlands Gateway area with travel to Birmingham. You will assist the Quality department to ensure regulatory and client requirements are met, supporting GDP, ISO 9001 and 13485 compliance across internal and supplier processes.

The role requires meticulous organisational ability, ability to manage changing priorities, and experience with QA documentation and audits.

Qualifications

• Experience in quality administration and QA support in healthcare or medical devices is advantageous.
• Knowledge of GDP, ISO 9001 and ISO 13485 and SAP usage.
• Proficiency with Office applications and data handling.

Responsibilities

• Provide QA support to internal departments to ensure GDP compliance with Arvato procedures.
• Initiate and maintain change control, deviation and CAPA records.
• Support QA scheduling of suppliers, internal audits, and annual reviews.
• Collate data for reports, KPIs, and quality metrics.
• Assist in self-inspection audit programmes and client/regulatory inspections.

Skills

Quality administration

Stakeholder liaison

Organisational skills

Prioritisation

Tools

SAP

Electronic QMS

Temperature monitoring portals

Microsoft Office

Job description

Job Description

Salary: Up to £42,000.00 depending upon experience.

Location: East Midlands Gateway with Travel to Kings Norton in Birmingham

Hours: 40 hours per week, Monday to Friday 8.30-17.00 (flex on start/ finish available)

You’ll assist the Quality department in supporting the Quality Management System (QMS) by providing efficiencies in administration and promoting continual compliance to regulatory and client requirements with the internal departments, and suppliers.

Your Tasks

• Provide QA support to internal departments to ensure activities are undertaken in compliance with GDP and Arvato procedures,
• Provide quality assurance support/ advice to operational departments in support of compliance to process.
• Initiate and maintain change control, deviation and Corrective and Preventative Action (CAPA) records ensuring effectiveness of activities proposed.
• Provide administrative support to QA scheduling of suppliers, internal audits, and annual reviews
• Collate data to be used in reports, investigations, key performance indicators (KPIs), and other quality metrics.
• Participate in the self-inspection audit programme when required by supporting the QA management team.
• Support Client audits and regulatory inspections by prepping documents and ensuring audit readiness by scheduling internal team prep.
• Support the Supplier Management process, including verifications, audit actions, and surveys.
• Aid as necessary, the Quality Management System in line with GDP, ISO 9001, and 13485.
• Liaise with internal and external stakeholders relating to QMS activities or non-compliance actions linked to co-ordinator tasks and build relationships and trust.
• Support client onboarding ensuring compliance with QMS activities including validation, SAP testing, and process walk-throughs.
• Support the ongoing compliance with the Arvato Global Quality system, and report KPIs into the Global QA team.
• Support product quality, process safety and complaint investigations.
• Complete QA review on inbound packs, return documentation, and temperature data management, ensuring documentation is completed to ALCOA principles and archived according to client requirements.

Qualifications

The ideal candidate will be organised, methodical, and can prioritise a busy workload and be able to liaise with stakeholders and customers of all levels.

• We are also looking for experience in:
• Quality administration; managing a busy mailbox, control of documents, scheduling, annual supplier/client audits, and information
• 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.

Additional Information

• 25 days annual leave plus 8 bank holidays 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 Benefit Hub
• Free Parking