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Quality Assurance Validation Specialist- based Leighton Buzzard in London at UPS

Date Posted: 11/26/2018

Job Snapshot

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Job Description


Polar Speed, a UPS company, is a logistics company and innovative provider of temperature sensitive transportation and pharmaceutical supply chain solutions in the UK.



ATTRACTIVE – 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 looking for a Validation Specialist to join our expanding Quality Assurance Team.

As a Validation Specialist you will report to the Head of Quality Assurance and Regulatory Affairs you will provide guidance to Operations or Information Technology to ensure validation of facilities, vehicle chambers or other systems utilised for Healthcare applications are maintained.

Your responsibilities will include monitoring validation, including assess facilities or systems being evaluated for use in healthcare applications, provide training and expertise to achieve and maintain validated status, identifying facilities, vehicle chambers or systems requiring validation escalating all issues appropriately ensuring all documentation is in place.

You will also be responsible for defining the applicable regulations and capabilities for the storage and transportation of clients’ healthcare products.

To support audits and inspections ensuring that the department is inspection ready at all times.

The position is 40 hours a week, Monday to Friday starting at 0830 hours and finishing at 1730 hours.

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, a company pension and life assurance scheme.

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

Key responsibilities:

•Identify facilities, chambers or systems requiring validation creating development plans and documents.

•Participation in management reviews identifying issues and escalating accordingly.

•Develop change control protocols, training, audits generating validation reports performing corrective procedures when required.

•Consult with internal groups investigating and resolving healthcare issues, review policies procedures and regulations with clients in line with policies, procedures and regulatory requirements.

•Manage all relevant documents and procedures including writing and revising Standard Operating Procedures (SOP) and work instructions, coordinate document and data control to meet quality standards.

•Implement training programs and support materials to train QA’s and internal clients on SOPS.

•Participate in audits and inspections – information gathering, recording information & observations from internal sources to support preparation of audit reports, host and respond to corporate compliance and regulatory agency inspections and dealing with all relevant outcomes accordingly.

Key Skills/Experience/Requirements:

•General experience within healthcare industry, Pharmaceuticals, Medical devices or other relevant field.

•General Validation qualification or experience and knowledge, common methods industry best practice.

•Specific Validation/ Qualification experience and or knowledge related to Healthcare products storage environments (warehousing, cold chambers such as cooler, freezers)

•Qualification of Transportation of Healthcare products such as temperature-controlled trailers


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