Job Posting Title: Quality Manager - Level 3
Site: Hertfordshire SG12 0DP
Duration: 6 months
Onsite
Hours per Day 7.5
Hours per Week 37.5
due to mat cover
broad ranging QA role - need experience in QA docs for blenders, chillers, chill rooms, powders, HPLC’s, infrastructure and utilities validation documentation, review of change controls, audit, deviation
Job Description:
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 million vaccine doses in 2021.
We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.
QA Role
Are you a Quality Assurance Professional seeking an opportunity to leverage and/or build upon your expertise in validation (inclusive of equipment, utilities, facilities, computer systems) working with internal and external business partners for R&D?
Do you enjoy a varied day dealing with challenges and answering the call for advice on different scenarios? If yes, this role in Pharma R&D may be the right opportunity for you to explore.
This is a great opportunity where you will deal with various situations, which you will need to provide solutions, so good problem solving skills are a must. Within QA you will be presented with issues and business proposals which you will be asked your advice to ensure quality and the patient is not affected while allowing us to grow and develop as a competitive business. You will work cross functionally with different teams, gaining experience of providing key project management direction, pilot plant systems, analytical systems, medical devices, utilities and facilities.
This role will be based at Ware R&D.
Job Purpose
In this QA role in Pharma R&D, Infrastructure and Validation team, you will perform the quality assurance activities and quality oversight of the Validation and GMP facilities management activities performed within Pharma R&D across the UK sites.
In this role you will be key in the following areas…
• Providing review and approval of validation lifecycle documents from a variety of QMS within the company. Provide meaningful comments to ensure compliance with regulatory expectations/requirements.
• Provide quality oversight of internal business groups and external services partners inclusive of the following quality processes:
• Change control
• Deviation investigation inclusive of CAPA.
• May support project work as a QA representative, quality program or team activities.
• Provide advice and consultancy to project teams, internal business groups and external partners to reduce regulatory risk.
Preferred Qualifications & Skills:
• Proven working experience in biopharma/pharmaceutical Industry related to Quality Assurance Job scope.
· Experience of validation of analytical systems, cold chain storage, secondary manufacturing equipment, utilities and infrastructure. Computer validation if possible for networked systems and corporate facing applications.
• Ability to manage workload prioritisation in a fast paced changing environment.
• Excellent organisational skills
• Strong interpersonal skills.
• Strong written and verbal communication skills.
• A good team player and able to work independently.
• Experience with key Quality activities (i.e. Deviations Change Controls)