Compliance Professional

5 days ago


Irvine, North Ayrshire, United Kingdom GSK Full time
Job Overview
As a Compliance Specialist at GSK, you will play a crucial role in ensuring the site complies with cGMP, the GSK Quality Management System, and all regulatory, licensing, and pharmacopeia requirements. Your primary responsibility will be to manage the QMS implementation process, ensuring that all QMS documents are assessed for QMS applicability and deployment. Additionally, you will act as a QMS Champion, providing support, training, and coaching to site personnel, as well as partnering with the Central Group as required.

Responsibilities:
  • Manage the QMS implementation process, ensuring all QMS documents are assessed for QMS applicability and deployment.
  • Act as a QMS Champion, providing support, training, and coaching to site personnel, as well as partnering with the Central Group as required.
  • Manage the site management monitoring audit program, ensuring delivery of cGMP compliance, QMS "in place" and "in use" expectations to deliver inspection readiness.
  • 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 QRI process at site, ensuring the site responds to relevant QRI and communicates to Quality Council.
  • Own and manage the site change control process for all quality-impacting changes, ensuring all targets are met and performance is tracked and communicated as required.

Requirements:
  • 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.

Preferred Qualifications:
  • Auditing experience.
  • High attention to detail.
  • Good influencing, communication, and coaching skills.


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