Quality Assurance Specialist

BASED: POLAR SPEED DISTRIBUTION LIMITED, SITE 2, CHARTMOOR ROAD, LEIGHTON BUZZARD, LU7 4WG

HOURS : 08:00 - 17:00 - MONDAY - FRIDAY - 40 HOURS PER WEEK

SALARY: £38,000.00 PER ANNUM

Polar Speed has a reputation for quality, compliance, operational and customer facing technology and monitoring solutions in the growing temperature-sensitive pharmaceutical logistics market in the UK. The company specialises in active temperature-controlled deliveries to hospitals, pharmacies, wholesalers and medical care surgeries as well as to end patients which it serves through its homecare business. Its customers include some of the best known pharmaceutical brands in the world.

We currently have a vacancy based in our Quality department at our busy Leighton Buzzard office.

You will be required to support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with EU GDP guidelines.

Ideally you will have experience of working in a GMDP environment.

We are looking for a candidate who has a proactive attitude, who can work collaboratively to support all areas of the business in achieving our Quality objectives. Our new QA Specialist will need to engage with internal and external stakeholders to support the continuous improvement of our systems and processes and act as a role model to promote a positive quality culture within the business.

We offer a wide range of benefits including 28 days holiday(including bank holidays) building to 33 days(including bank holidays) in the sixth full holiday year(PRO-RATA), a company pension with 5% company contribution, and UPS Perks At Work Scheme, plus Private Healthcare.

For successful applicants, Polar Speed will process basic disclosure criminal record checks.

Key responsibilities:

Supporting the Head of QA & RA, QA Managers, Responsible Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards.

Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures.

Promoting a positive Quality culture within the organisation.

Supporting Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings and the management of the meetings outputs.

Supporting Regulatory, ISO and Client audits, and conducting Supplier audits, internal audits, and self inspections, including the preparation of responses and CAPA plans.

Key Skills/Experience/Requirements:

Strong organisational and communication skills, with excellent attention to detail.

Ability to show initiative and be proactive, working well under pressure and to meet deadlines.

Ability to build effective working relationships with other members of the QA teams, internal customers, and clients, along with the various departments across the whole Polar Speed Network.

Good understanding of the Quality standards required and able to promote a positive Quality culture within the company.

Excellent knowledge of Word, Outlook, Excel, PowerPoint, and Teams.

Good knowledge of GDP, GMP and GPhC regulations, ISO 9001 and ISO 13485 standards.