- Role:
- Oversee key quality system elements, including Quality Management Reviews, Vendor Qualification, PQRs, and various audits.
- Maintain site registrations with regulatory agencies as required.
- Track site compliance commitments and follow up on actions.
- Provide Quality Compliance Metrics/KPIs to key stakeholders.
- Identify GxP trends and relay information to relevant parties.
- Support compliance risk management activities and execute risk mitigation plans.
- Collaborate with site functions to reduce occurrences of non-compliance and implement quality enhancements.
- Organize QMS training for site employees in line with current regulatory requirements.
- Take ownership of the Trackwise electronic QMS as the site system owner.
- Monitor regulatory findings and trends that could prompt regulatory inspections.
- Act as the Single Point of Contact between the site and Corporate Quality Team as directed by the QA Manager.
- Ensure procedural compliance according to internal guidelines and regulatory standards.
- Lead Quality Management Review meetings, emphasizing GxP areas of concern and tracking necessary actions.
- Assist in quality-related investigations and contribute to the development and approval of effective CAPA to address product, audit, and customer issues.
- Prepare for, manage, and follow up on customer audits and regulatory inspections.
- Report any significant quality or regulatory breaches to the QA Manager (Compliance) and Head of Quality.
- Stay current with quality standards, guidelines, and best practices, fostering compliance by enhancing understanding.
- Maintain positive working relationships between QA, site personnel, and stakeholders.
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Regulatory Affairs Lead - Grangemouth, Falkirk, United Kingdom - Piramal Pharma Solutions
Description
Job Description: The QA TL (Compliance) role focuses on ensuring governance and compliance of the Pharmaceutical Quality Management System (PQS), along with managing Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth.
The individual in this position will be responsible for coordinating, maintaining, and championing compliance efforts, driving continuous improvement in quality and regulatory systems.
The role involves supporting and verifying site and related functions' adherence to GxP regulations and relevant quality guidelines, such as UK/EU/US GMP/GDP, ICH, and region-specific directives.
