Pharmaceutical Regulatory Affairs Specialist

4 weeks ago

Grangemouth Falkirk, United Kingdom Piramal Pharma Solutions Full time

The role of the QA Compliance Specialist is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and regulatory systems.
The role will support and ensure that the site and related functions are in 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 ownership for key quality system elements and will support and execute site quality and compliance improvements, working closely with relevant stakeholders on site

Role

•Compliance governance of key quality system elements, including scheduling and completion of; Quality Management Reviews, Qualification of Vendors, PQRs, Audits (Self-Inspections, Vendor Audits, Customer Audits).
•Maintain site establishment registrations with regulatory agencies as applicable.
•Manage updates to Drug Master Files and issuance of regulatory compliance reports
•Coordinate tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders.
•Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans.
•Working with the wider site functions to drive down out of compliance events, identify and implement quality improvements
•Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements
•Maintain responsibility as the site system owner for the Trackwise electronic QMS
•Support and track regulatory findings and trends that may lead into a focus of regulatory inspections
•Act as Single Point of Contact between site and Corporate Quality Team as delegated by QA Manager
•Assure compliance of procedures 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.

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