QA Compliance Lead — Quality & Regulatory Readiness

Piramal Pharma Solutions; Grangemouth; Presencial; GBP 65.000 - 95.000; Jornada completa

Descripción de la vacante

Piramal Pharma Solutions in Grangemouth is seeking a QA Team Leader (Compliance) to own elements of the Pharmaceutical Quality Management System across the site. You will provide quality and compliance expertise, identify risks, resolve issues and drive continuous improvement in collaboration with Quality, Manufacturing, Engineering, Supply Chain and IT.

The role requires strong GMP experience, GxP knowledge and the ability to influence stakeholders at all levels.

Formación

• Experience within Quality Assurance in a GMP environment.
• Strong knowledge of GxP requirements and relevant UK, EU, US and ICH quality guidance.
• Experience performing self-inspections and/or audits of third-party suppliers.
• Experience monitoring Quality Management Systems, including deviations, investigations, CAPA and complaints.
• Experience implementing audit and vendor assurance processes.
• Strong attention to detail, risk-based decision-making and communication skills.
• Lead Auditor qualifications or MHRA/FDA inspection support experience is advantageous.

Responsabilidades

• Provide governance across key elements of the Pharmaceutical Quality Management System.
• Coordinate Quality Management Reviews and translate trends into actions.
• Support supplier qualification and audit programmes, including self-inspections and vendor audits.
• Assist regulatory inspections and post-inspection follow-up.
• Identify GxP trends and develop mitigation plans with stakeholders.
• Coordinate site QMS training and maintain understanding of regulatory requirements.

Conocimientos

Quality Assurance

GxP compliance

Auditing

Regulatory liaison

Risk assessment

Educación

Bachelor's degree in a relevant field

Herramientas

QMS software

Descripción del empleo

Piramal Pharma Solutions in Grangemouth is seeking a QA Team Leader (Compliance) to own elements of the Pharmaceutical Quality Management System across the site. You will provide quality and compliance expertise, identify risks, resolve issues and drive continuous improvement in collaboration with Quality, Manufacturing, Engineering, Supply Chain and IT.

The role requires strong GMP experience, GxP knowledge and the ability to influence stakeholders at all levels.