Quality Assurance Specialist

Quality Assurance Specialist

Based:
Polar Speed Distribution Ltd, Site2, 8 Chartmoor Road, Leighton Buzzard, Bedfordshire, LU7 4WG

Monday to Friday, 40 hours a week

• Supporting 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 and GPhC, ISO 9001 and ISO 13485 standards.
• Supporting ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures.
• Promoting a positive quality culture within the organisation.
• Supporting quality system management reviews, including preparation of meeting inputs, attendance, presentation at meetings and management of meeting outputs.
• Supporting regulatory, ISO and client audits, and conducting supplier audits, internal audits and self inspections, including preparation of responses and CAPA plans.
• Preparing draft quality technical agreements for clients and suppliers.
• Supporting in the preparation and review of risk assessments for quality risk management and change requests.
• Ensuring effective control of all documentation within the quality management team in line with procedures for control of documents, physical and electronic records.
• Investigation and reporting of incidents including deviations, non conformances, client feedback and customer complaints, including logging, notification, investigation, reporting and approval of incidents.
• Collaborating with the RPs to urgently and accurately perform all operations required during a pharmaceutical call.
• Reviewing and logging all MHRA product recall notifications.
• Assisting with the implementation and maintenance of company training programs.
• Assisting with monitoring and evaluation trends in warehouse and vehicle temperature conditions to ensure that products and orders are stored and transported in the correct conditions.
• Reviewing and approving records relating to premises and equipment, including temperature records, alarm tests, cleaning logs, pest control reports and calibration certificates.
• Completing client quality questionnaires and providing support to clients when qualifying Polar Speed as a supplier.
• Participating in the qualification and ongoing management of suppliers, customers and outsourced service providers.
• Conduct fortnightly regulatory checks of suspended, cancelled, terminated and revoked licences.
• Support with completion of returns forms and management of returns products.
• Providing QA oversight on quarantined stock, ensuring accuracy in identifying quarantined and released products.
• Preparing quality statements requested by clients to confirm product storage conditions.
• Preparing and reviewing the documentation packs for the RPI release of imported medicinal products.
• Completing the quality control checks required for GMP activities.
• Producing and evaluating QA and KPI reports for internal and external customers.
• Participating in client meetings to discuss QA related activities, including incident investigations, CAPA, change control and risk assessment.

Permanent

Entry level

Full-time

Quality Assurance

Truck Transportation

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