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

About Polar Speed:

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 specializes 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.

Role Overview:

We are now looking for a QA Manager and Responsible Person to join our busy QA team at our Leighton Buzzard HUB or Birmingham HUB. 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.

Key Responsibilities:

1. 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, GPhC, ISO 9001, and ISO 13485 standards.
2. Ensuring ongoing compliance with relevant standards, legal requirements, regulations, and the PSDL documented policies and procedures.
3. Promoting a positive quality culture within the organization.
4. Participating in Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings, and the management of the meeting outputs.
5. 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:

1. Exceptional knowledge of GDP and the ISO 9001 standard; understanding of ISO 13485 would be an advantage.
2. Eligibility to become GDP Responsible Person and Responsible Person for Import.
3. Good communication skills to support internal and external customer queries both verbally and in writing.
4. Strong organizational and communication skills, with excellent attention to detail.
5. Excellent people management skills; previous line management experience would be an advantage.
6. Flexible in working hours, with the ability to travel within the UK on a monthly basis.
7. Good knowledge of Microsoft Office, Excel, PowerPoint, and Visio.

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 a 10% performance-related bonus incentive.

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

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