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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:

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 the GMP and GDP guidelines and GPhC, ISO9001 and ISO 13485 standards.

Supporting ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures.

Promote a positive quality culture within the organisation.

Supporting quality system management reviews, including the preparation of meeting inputs, attendance and presentation at meetings and the management of the meeting outputs.

Supporting regulatory, ISO and client audits, and conducting supplier audits, internal audits and self inspections, including the 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 the effective control of all documentation within the quality management team in line with procedures for the control of documents, physical and electronic records.

Investigation and reporting of incidents including deviations, non conformances, client feedback and customer compliants, including the 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 the 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 of 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 quarantined stock, to ensure accuracy in identifying quarantined and released products.

Preparing quality statements requested by clients to confirm product storage conditions.

Preparing and review the documentation packs for the RPI release of imported medicinal products.

Complete 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.

Employee Type:
 

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