Details:
- Job Type: Permanent
- Job Status: Full-Time
- Location: Falkirk
- Date: 1 day ago
Description:
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.
Guidant, Carbon60, Lorien & SRG - The Vertage Group Portfolio are acting as an Employment Business in relation to this vacancy