QA Manager & Responsible Person

BASED: POLAR SPEED DISTRIBUTION LIMITED, SITE2 Chartmoor Road, Leighton Buzzard, LU7 4WG

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

SALARY:£65,000.00 - £85,000.00 PER ANNUM - Dependant on experience

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 are now looking for a QA Manager and Responsible Person to join our busy QA team at the Leighton Buzzard Site 2 office.

You will be required to support the Head of QA, Responsible Person and Responsible Person for Import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with the EU GDP guidelines.

Ideally you will have extensive experience of acting as a Responsible Person and Responsible Person for Import on a WDA licence.

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 Manager 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) and a company pension scheme, with 5% company contribution, private healthcare, UPS perks at Work scheme, and 10% performance related bonus incentive.

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

Key responsibilities:

Supporting the Head of QA & RA, 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.

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

Promoting a positive quality culture within the organisation.

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

Hosting and supporting in regulatory ISO and Client audits and conducting Supplier audits, internal audits, and self inspections, including the preparation of CAPA plans.

Key Skills/Experience/Requirements:

Exceptional knowledge of GDP and the ISO 9001 standard, understanding of ISO 13485 would be an advantage

Eligibility to become GDP Responsible Person and Responsible Person for Import

Good communication skills to support internal and external customer queries both verbally and in writing

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

Excellent people management skills, previous line management experience would be an advantage

Flexible in working hours, with the ability to travel within the UK on a monthly basis

Good knowledge of Microsoft Office, Excel, Power Point and Visio