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Quality Assurance Associate
You will like
Working in QA in Elstree near Watford for this global pharmaceutical firm, providing medicine and essential medical products, to people worldwide before, during & after the Covid-19 pandemic. They prioritise emerging markets, partnering with innovative companies to deliver their products to the regions they cannot reach and are renowned for quality in time-critical, temperature-controlled supply chain and logistics and GDP compliance.
You will like
The Quality Assurance Associate QA Associate job itself where you will be working in a QA team of 3 and reporting to the QA Manager engaging with departments across the organisation.
You 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. More specifically:
* 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.
Quality Management System
* Maintain and regularly update the 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.
You will have
To be successful as Quality Assurance Associate QA you will bring proven experience in Good Distribution Practice (GDP) quality systems, SOP development, temperature excursion handling, and KPI management. Plus a healthy mix of the following
* Experience in utilising quality system processes (such as, Audit, Deviations, CAPA, Change Control)
* Excellent administrative and people skills
* Strong communication skills, with excellent English language skills, (oral and written)
* A good team player demonstrating a willingness to learn, improve and adapt
* Strong analytical and problem solving skills, with experience of route cause analysis
* Possess the ability to work productively and diligently, with initiative and drive, under tight timescales and pressure whilst maintaining high-quality standards
* Proficient in the use of MS Office applications, especially, Word, Excel and Power Point
You will get
As QA Associate you will enjoy competitive salary ~£35K-£40K DOE + Bonus + Package
You can apply
To Quality Assurance Associate QA Associate pushing the button on this job posting (recommended), or by sending CV in confidence to (url removed)
UK_MS
£35000 – £40000/annum