Job Description
Quality Assurance (QA) Officer / Associate
Office based Monday to Friday in Elstree, Herts
£35,000 - £40,000
My client is a global pharmaceutical company dedicated to delivering life-changing medicines to patients in need.
Working in a QA team of 3 and reporting to the QA Manager the successful candidate will engage with departments across the organisation and bring prior experience in a Pharmaceutical Good Distribution Practice (GDP) environment.
Position Summary:
The job holder will be responsible for the day-to-day management of quality-related activities, including excursions, supplier and customer qualifications, deviations, CAPAs, change controls, and risk mitigation efforts. This role requires close collaboration with the Responsible Person (RP/RPi) and other departments across the business.
The successful candidate will bring proven experience in Good Distribution Practice (GDP) quality systems, SOP development, temperature excursion handling, and KPI management. They will also participate in both internal and external audits.
Key Responsibilities:
* Support the QA Manager in executing assigned Quality Assurance (QA) responsibilities.
* Ensure all planned, scheduled, and unplanned QA activities are carried out, documented, and reported in accordance with company procedures.
* Assist in the management and continuous improvement of the company’s Quality Management System (QMS).
* Promote and embed continuous improvement principles across QA processes and documentation.
Key Duties:
Quality Management System
* Maintain and regularly update the company Training Matrix and Schedule, coordinating with department managers and QA to ensure all training is current and compliant.
* Monitor and manage the Document Control Log, ensuring accurate tracking of all controlled documents.
* Oversee the lifecycle of quality documents (SOPs, Work Instructions, Forms, Policies, etc.), from training and implementation to archiving and secure storage.
* Provide administrative support to the QA Department
* Assist in the planning and preparation for internal and external audits and inspections.
Change Control, CAPA, and Deviation Management
* Track, update, and support the implementation of Corrective and Preventive Actions (CAPAs).
* Collaborate with cross-functional teams to ensure timely execution and compliance with procedures related to change controls, deviations, complaints, and internal GDP audit follow-ups.
* Assist in the investigation and documentation of quality incidents.
Qualification and Compliance Monitoring
* Conduct regular compliance checks using MHRA and other regulatory resources.
* Shadow / support internal compliance audits to ensure adherence to GDP and company standards.
* Carry out monthly compliance checks on import/export processes.
* Support the retrieval, review, and closure of temperature monitoring reports.
* Assist departments in conducting customer and supplier bona fide checks.
Staff Training Administration
* Administer competency assessments linked to SOP training.
* Notify relevant staff of upcoming or overdue competency tests, referencing the training matrix.
* Receive tests and maintain accurate training records.
* Inform line managers of any non-compliance, including failed assessments or missed deadlines.
Quality Risk Management
* Support Quality Risk Management and route qualification activities.
* Understand and support validation activities.
For more information and to apply please send your CV