Compliance Officer (Pharma)

Full Job 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.

Role

•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.

•Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.

•Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.

•Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections.

•Escalate any significant breach of quality or regulatory compliance to Quality Management.

•Maintain productive working relationships with other site personnel and stakeholders.