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Job Description:
Quality Assurance Specialist
Based: Polar Speed Distribution Ltd, Site2, 8 Chartmoor Road, Leighton Buzzard, Bedfordshire, LU7 4WG
Salary: £38,000 per annum
Monday to Friday working 40 hours a week
Key Responsibilities:
* Support the head of QA and RA, QA managers, responsible persons, and qualified persons with the implementation and maintenance of the quality management system in accordance with GMP, GDP guidelines, GPhC, ISO9001, and ISO 13485 standards.
* Ensure ongoing compliance with relevant standards, legal requirements, regulations, and company policies.
* Promote a positive quality culture within the organization.
* Assist in quality system management reviews, including preparing inputs, attending meetings, presenting, and managing outputs.
* Support audits (regulatory, ISO, client, supplier, internal, and self-inspections), including response preparation and CAPA plans.
* Draft quality technical agreements for clients and suppliers.
* Assist in preparing and reviewing risk assessments and change requests for quality risk management.
* Maintain effective control of all documentation in line with procedures for document control and records management.
* Investigate and report incidents such as deviations, non-conformances, client feedback, and complaints, including logging, notification, investigation, and reporting.
* Collaborate with Responsible Persons during pharmaceutical calls.
* Review and log MHRA product recall notifications.
* Support the implementation and maintenance of company training programs.
* Monitor warehouse and vehicle temperature conditions to ensure proper storage and transport.
* Review and approve records related to premises and equipment, including temperature logs, alarm tests, cleaning logs, pest control reports, and calibration certificates.
* Complete client quality questionnaires and support client qualification processes.
* Participate in qualification and ongoing management of suppliers, customers, and service providers.
* Conduct regular checks of licenses and manage returns products.
* Oversee quarantined stock to ensure accurate identification and status.
* Prepare quality statements for clients regarding product storage conditions.
* Review documentation for RPI release of imported medicinal products.
* Perform GMP-related quality control checks.
* Generate and evaluate QA and KPI reports for internal and external stakeholders.
* Participate in client meetings discussing QA activities, incident investigations, CAPA, change control, and risk assessments.
Employee Type: Permanent
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