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Working for this global pharmaceutical distribution firm, providing medicine and essential medical products, to people worldwide before, during & after Covid-19. 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.
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The Senior Quality Assurance (QA) Associate job itself at an interesting and challenging workplace, with a diverse range of products, suppliers and customers, both UK and international, from pharmacies to wholesalers to hospitals. Multiple products sourced from multiple suppliers in multiple countries dispatched to multiple customers in multiple countries. The product range includes prescription-only medicines, OTCs, devices, brands, generics and PIs, ambient temperature and fridge lines, controlled drugs and health foods. Orders are both small and large, and of moderate to extremely high values. A fully functioning and robust QMS exists and is continually evolving, amongst a small QA team which is always busy and continually working to tight deadlines.
We are seeking a c to play a vital role in monitoring and maintaining the Quality Management System to ensure compliance with GDP and to support continuous improvement activities. The role of Senior QA Associate will have a degree of autonomy that allows them to work on their own initiative and make proposals to the QA Manager and Responsible Person/ Responsible Person Import (RP/RPi) with regard to quality and quality improvements. The job holder will assume responsibility for the day-to-day management of excursions, supplier/customer qualification, deviations, CAPA, change control and risk mitigation activities. Working closely with the RP/RPi and QA Manager the successful candidate will bring proven experience of GDP Quality Systems, SOP development, temperature excursions and KPI management. The successful candidate will be expected to work closely with all departments, across the company and undertake internal and external audits.
The position offers the successful candidate the opportunity to develop towards the position of RP/RP-i on the WDA(H), initially through deputising duties. More specifically:
- Management of deviation, complaints, CAPAs and change controls
- Qualification of new and existing customers and suppliers
- Support product approvals and maintenance of existing products
- Support RP-i release of medicines licensed in the UK but manufactured in EEA
- Review of controlled drugs licensure
- Review and decide on products impacted by temperature excursion
- Understand and support introduced medicines and related responsibility
- Assist with the internal staff training and general document control
- Lead weekly Quality meetings as deputy
- Plan and schedule internal audits and where required external audit
- Understand and implement GDP regulations and guidance
- Assist in the management of the Quality Management System (QMS)
- Ensuring continuous improvement principles are embedded and the site is inspection ready
- Provide specialised training to staff
- Perform Quality Risk Management activities, support route qualification activities
- Understand and support validation activities
- Actively working towards becoming deputy RP-i
- Engaging in research, learning and training activities to enhance knowledge and capability.
You will have
To be successful as the Senior Quality Assurance (QA) Associate you will have attributes in keeping with company ethos – professional, hands-on and results-driven. You will be motivated to achieve success, but also work collaboratively with their colleagues to achieve the company goals.
Essential
- Degree qualified in a relevant pharmaceutical or related subject
- Experience of working across inter-company functions or multi-company roles with increasing responsibilities and leadership skills
- The required skills and attributes for becoming a qualified RP-i, as set out by the MHRA
- Previous experience in a GDP environment
- Strong organisational skills with prior, demonstrable experience in deviation/CAPA management, change control and risk management
- A good team player demonstrating a willingness to learn, improve and adapt · Strong analytical and problem-solving skills
- Excellent communication and influencing skills
- Proficiency and accuracy in the use of MS Office applications, especially, Word and Excel, (PowerPoint and Visio would be an advantage)
- Experience of report writing and QTA’s
- Experience of performing Internal Audits
- Experience of performing External Audits.
Desirable
- A qualified pharmacist
- Having experience of working with a manual QMS, and involvement in the planning and implementation of a QM software system application
- The ability to present to and train all levels of staff
- Experience of working with remote team members in a collaborative environment
- Proficient in using SAP
- A desire to manage others in the future.
You will get
As Senior Quality Assurance (QA) Associate, you will enjoy a highly competitive salary to £40K + Bonus + Package
You can apply
To Senior Quality Assurance (QA) Associate by pushing the button on this job posting (recommended), or by sending CV in confidence to anthony@macstaff.co.uk
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