SRG
QA Compliance Officer
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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, licenses, 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.
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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).
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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.
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