Job Title: Senior Quality Specialist
Reporting To: Quality Lead
Employment Type: Full-Time
About the Role
Our client is seeking an experienced Senior Quality Specialist to join their growing Quality team within a regulated, ISO-certified environment. This is a key role focused on maintaining and continuously improving the Quality Management System (QMS), with a strong emphasis on supplier and customer quality management.
The successful candidate will play a critical role in ensuring compliance with GMP and cGxP guidelines, supporting multinational customers in the bio/pharmaceutical market, and safeguarding product quality, patient safety, and supply chain integrity.
This position requires a proactive, collaborative professional who thrives in cross-functional environments and takes ownership of quality systems and processes.
Key Responsibilities
- Lead investigation and documentation of non-conformances
Draft and execute Change Controls and CAPAs in a timely manner
- Maintain and update QMS tracking tools and quality records
- Perform Batch Record Review and material release (including CoA) in compliance with GMP requirements
- Conduct QA review and approval of SOPs, Work Instructions, and associated documentation
- Manage and support supplier approval processes
- Coordinate customer and supply chain quality notifications
- Support and execute internal and external audits, including regulatory and customer audits
- Perform product release activities
- Drive continuous improvement initiatives across the QMS
- Contribute to monitoring and improving quality KPI metrics
Experience & Qualifications
- 3-5+ years' experience in a Quality role within a GMP or regulated environment
- Background in Bio/Pharmaceutical, Medical Device, Nutraceutical, or Food Science sectors
- Degree in Science, Engineering, Technology, or related scientific discipline
- Direct exposure to customer and regulatory audits
- Prior experience as a system owner within a QMS
- Strong understanding of GMP and cGxP requirements
- Excellent documentation, communication, and cross-functional collaboration skills
What Our Client Is Looking For
- A detail-oriented and highly organised quality professional
- Strong analytical and problem-solving capabilities
- Confident communicator with the ability to engage with customers and suppliers
- A proactive mindset with a commitment to continuous improvement
This is an excellent opportunity for a motivated Quality professional looking to take the next step in their career within a dynamic and highly regulated industry.
