ob Description

The role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications.

The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have support key quality system elements and compliance improvements, working closely with relevant stakeholders on site.

Key Roles/Responsibilities:

•Supporting key quality system elements, including activities relating to QMS monitoring, Qualification of Vendors, Audits (Self-Inspections, Vendor Audits, Customer Audits).

•Support updates to regulatory agency registrations as applicable.

•Support tracking of site compliance commitments and follow up actions.

•Working with the wider site functions to drive down out of compliance events and implement quality improvements

•Support and track regulatory findings and trends that may lead into a focus of regulatory inspections

•Support review of procedures and other QMS related documentation according to internal guidelines and UK/EU/US/ICH and other region specific guidance.