Compliance Specialist

As our Compliance Specialist, you will ensure that the site complies with cGMP, the GSK Quality Management System and all regulatory, licensing and pharmacopeia requirements.,

• Manage the site management monitoring audit program ensuring delivery of cGMP compliance, QMS "in place" and "in use" expectations to deliver inspection readiness. Manage the Level 1 Auditor Certification programme on site and maintain capability via training, mentoring, and coaching.
• Support site pest control program and all Level 3 / 4 inspections.
• Carry out verification of audit CAPA, as required to ensure these are "in place", "in use" and effective.
• Manage the QMS implementation process ensuring that all QMS documents are assessed regarding QMS applicability and deployment.
• Act as QMS Champion across all site operations providing support, training, coaching for site personnel as well as partnering with the Central Group as required.
• Manage the QRI process at site ensure the site responds to relevant QRI, and communicate to Quality Council
• Own and manage the site change control process for all quality impacting changes. Ensure all targets are met, performance tracked and communicated as required.
• Drive and improve the compliance culture to ensure audit readiness via coaching, mentoring and training., 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.
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• Degree in a relevant science subject or suitable extensive experience in an appropriate discipline within a pharmaceutical environment
• Experience in interpreting regulatory expectations and QMS
• Experience in resolving cGMP / compliance issues., Auditing experience
• High attention to detail
• Good influencing, communication and coaching skills
  
  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.