Overview
In this role, you will support compliance across production operations by coordinating quality system activities, maintaining controlled documentation, and driving continuous improvement. You will work closely with Manufacturing, Quality, Technical, and EHS teams to ensure GMP/GDP-aligned processes. The position involves handling quality investigations, CAPAs, and audits across multi-shift production. You will help shape compliant, efficient operations within the manufacturing environment.
Responsibilities
- Coordinate and track Production Quality Management System activities to ensure ongoing compliance
- Create, review, and update production batch documentation
- Author and maintain SOPs and training records in collaboration with subject matter experts
- Support quality and risk assessment activities, including QRA and EHS assessments
- Manage and follow up CAPAs, action items, and effectiveness checks
- Participate in quality investigations and deviation management activities
- Support internal audits, inspections, and compliance-related initiatives
- Work collaboratively across Production, Quality Assurance, Technical Services, HR, and EHS functions
- Contribute to continuous improvement projects that enhance compliance, efficiency, and operational performance
- Ensure all activities are conducted in line with GMP, GDP, company procedures, and industry regulations
Key requirements
- Strong attention to detail and excellent documentation skills
- Good organisational and administrative abilities
- Effective written and verbal communication skills
- Ability to build positive working relationships across departments
- Strong prioritisation and time management skills
- Proactive and collaborative approach to problem-solving
- Competency with Microsoft Office applications
- Knowledge of GMP regulations and pharmaceutical manufacturing environments would be advantageous
- Attention to detail
- Effective communicator
- Collaborative mindset
- Microsoft Office applications
- GMP regulations knowledge
- Pharmaceutical manufacturing environment familiarity
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