Quality Assurance Specialist

QUALITY ASSURANCE SPECIALIST

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 - Flexibility required to suit the needs of the business which may be of an urgent medical nature.

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 Birmingham 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 and want to advance your career to become a GDP Responsible Person and Responsible Person for Import. Training and support to develop the necessary skills will be provided as required.

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), Pension scheme with 5% company contribution, and UPS Perks At Work Scheme, Private Healthcare.

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

Key responsibilities:

Actively support quality processes such as non-conformance and CAPA management, change controls and risk assessments, and ensure that quality system is continuously improved with the objective of assuring GDP compliance.

Oversee the warehouse and transport operations on site and ensure that warehouse returns and exceptions are correctly processed in a timely manner.

Participate in regulatory and client audits, lead internal audits / self-inspections and prepare CAPA plans addressing any observations identified.

Investigation and reporting of incidents, including deviations, non-conformances, client feedback and customer complaints, including the logging, notification, investigation, reporting and approval of incidents.

Collaborating with the RP(s) to urgently and accurately perform all operations required during a pharmaceutical recall.

Key Skills/Experience/Requirements:

Good 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.

Good analytical and critical thinking skills.

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

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

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