QA Manager & Responsible Person

QUALITY ASSURANCE MANAGER & RESPONSIBLE PERSON

BASED: POLAR SPEED DISTRIBUTION LIMITED, NOBEL WAY, UNIT 10, THE HUB, BIRMINGHAM, B6 7EU

HOURS : 08:00 - 17:00 - MONDAY - FRIDAY - 40 HOURS PER WEEK - Shift patterns may vary to suit the needs of the business, which may be of an urgent medical nature.

SALARY: £55,000.00 - £65,000.00 PER ANNUM - Dependant on experience.

BONUS : 10% - Performance related.

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 Quality Assurance Manager and Responsible Person to be based at the Birmingham HUB to support our busy QA team across the network.

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 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), a company pension with 5% company contribution, and a UPS Perks At Work Scheme, Private Healthcare, 10% performance related bonus.

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

Key responsibilities:

Supporting the Head of QA and 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.

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

Promoting a positive quality culture within the organisation.

Hosting and 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:

* Must have been previously named as a Responsible Person and Responsible Person for Import on a WDA licence *

Excellent knowledge of GDP Regulations, and the ISO 9001 and/or ISO 13485 standards.

Minimum 3 years experience of experience in companies such as manufacturer / laboratories / distributors of pharmaceutical products, food, and feed.

Excellent communication skills to motivate the team and to support internal/external customer queries both verbally and in writing.

Good analytical and critical thinking skills.

Excellent people management skills.

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

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