QA Compliance Officer

SRG; Stirling; In loco; GBP 30.000 - 48.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Healthcare

Flexi-time

Descrizione del lavoro

SRG is seeking a QA Compliance Officer for a site-based role in central Scotland. The role ensures governance and compliance of the Pharmaceutical Quality Management System (PQS) across UK/EU/US GMP/GDP and ICH guidelines.

You will support QMS, audits, CAPA, and regulatory registrations on site in Stirling, collaborating with stakeholders to maintain high compliance standards.

Competenze

• Minimum 2 years' experience in QA within a GMP environment.
• Experience conducting internal or supplier audits.
• Experience with QMS documentation (SOPs, deviations, investigations, CAPA).

Mansioni

• Support QMS monitoring, supplier qualification, and audits.
• Maintain regulatory registrations, licences, and certifications.
• Track site compliance commitments and regulatory trends.
• Collaborate with site functions to reduce compliance issues and implement improvements.
• Review QMS documentation in line with regulatory guidance.
• Lead Quality Management Review meetings.
• Support investigations and develop CAPA.
• Prepare for regulatory and customer audits and support follow-up.
• Escalate significant compliance concerns to Quality Management.

Conoscenze

QA experience

GMP knowledge

Auditing

Documentation

Formazione

Degree in science/engineering

Strumenti

Microsoft Office

Descrizione del lavoro

About the Role

A leading pharmaceutical development and manufacturing organisation is seeking a QA Compliance Officer to support the governance and compliance of its Pharmaceutical Quality Management System (PQS). This role plays a key part in maintaining regulatory compliance across international standards including UK/EU/US GMP/GDP and ICH guidelines.

Please note, this is a site based role in central Scotland so you must be comfortable with on site working.

Key Responsibilities

• Support quality system elements such as QMS monitoring, supplier qualification, and audits.
• Assist in maintaining and updating regulatory registrations, licences, and certifications.
• Track site compliance commitments and regulatory trends.
• Collaborate with site functions to reduce compliance issues and implement improvements.
• Review QMS documentation in line with global regulatory guidance.
• Lead Quality Management Review meetings.
• Support investigations and develop effective CAPA.
• Prepare for regulatory and customer audits and support follow-up.
• Escalate significant compliance concerns to Quality Management.
• Build strong working relationships with stakeholders.

Essential Qualifications & Experience

• Degree or relevant qualification in a scientific, business, or engineering discipline.
• Minimum 2 years' experience in QA within a GMP environment.
• Experience conducting internal or supplier audits.
• Experience with QMS documentation (SOPs, deviations, investigations, CAPA).

Desirable Experience

• Certified Auditor training.
• Supplier/vendor/material approval experience.
• Experience supporting regulatory audits.

Key Competencies

• Strong attention to detail
• Problem-solving skills
• Excellent communication
• Proficiency in Microsoft Office applications

What is on Offer

• Excellent benefits package including enhanced pension, healthcare and flexi-time.
• Development and learning opportunities.