Shift Operational Quality Advisor (Orals)-2

The job holder will be the first line of contact for operational quality advice and support for Production and other site areas. The role will drive for early detection and help prevent potential quality issues. The Shift Operational Quality role is responsible for driving adoption and embedding of RCA/CAPA processes. As a member of the Site Quality team, the job holder will be accountable for advising, coaching and mentoring site staff on all relevant aspects of cGMP. Working alongside and supporting the Batch Release teams as required. In this role you will

• Provide Quality oversight in real time for operational, QC and Warehouse operations, with a focus on issue resolution, inspection readiness & deviation investigation.
• Real time review of incidents, issues and events to determine the correct incident categorisation, investigation and Quality approval for Manufacturing and Packaging departments.
• Use GPS process tools such as GEMBA / Process Confirmation / 5S techniques to review and identify weaknesses and recommend improvements within Quality, Manufacturing and Packaging processes.
• Support training activities of Production personnel for items such as GMP or other Quality related site mandated training as well as providing mentoring and coaching of production operators, supervisors, engineering craftsmen together with technical colleagues in all relevant aspects of GMP.
• Review and approve documents as the Quality representative such as SOPs and technical reports. Support Validation document review and understand the impacts of change control in the area.
• Review and verdict documents for bulk and intermediate product release, together with review of packaging documents, whilst maintaining an efficient service in line with customer demands for the release of manufactured batches as required.
  
  We are looking for professionals with these required skills to achieve our goals:
• A levels or equivalent in Science and Maths.
• Experience in a pharmaceutical manufacturing organisation.
• Experience in a Quality or Operational role.
• Good organisation and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
• Excellent communications and interpersonal skills at all levels both written and verbal. Good computer skills.
• Knowledge of deviation management and regulatory requirements.
Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus:
• Preferred Qualifications include a basic degree supplemented by substantial on-job or job-related experience.
• Understanding and ability to demonstrate use of continuous improvement techniques.
  
  Why GSK?
Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are., Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov