Company description:
Bertelsmann is a media, services and education company that operates in about 50 countries around the world. It includes the broadcaster RTL Group, the trade book publisher Penguin Random House, the magazine publisher Gruner + Jahr, the music company BMG, the service provider Arvato, the Bertelsmann Printing Group, the Bertelsmann Education Group, and Bertelsmann Investments, an international network of funds. The company has 117,000 employees and generated revenues of €17.1 billion in the 2015 financial year. Bertelsmann stands for creativity and entrepreneurship. This combination promotes first-class media content and innovative service solutions that inspire customers around the world
Job description:
Salary: Up to £35,000.00
Location: East Midlands Gateway with Travel to Kings Norton site
Hours: 40 hours per week, Monday to Friday
Youll 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 clientrequirements.
Your Profile
Someone who is organised, methodical, and can prioritise a busy workload and who can liaise with stakeholders and customers of all levels.
You will have 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.
What do we offer? 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 car parking
Profile description:
TPBN1_UKTJ