Quality Specialist Opportunity
We are seeking a highly motivated Quality Specialist to join our Quality Assurance team.
The Role:
As a Quality Specialist, you will be responsible for ensuring the continuous improvement of our Quality Management System (QMS), managing internal audits, supplier approvals, compliance processes, and overseeing the controlled drugs system.
Key Responsibilities:
* Oversee and enhance the Quality Management System (QMS) through audits, change control, and compliance initiatives.
* Conduct internal audits and manage supplier approval processes, ensuring compliance with regulatory requirements.
* Act as a deputy for the Quality Manager, reviewing and approving documentation while supervising staff when required.
* Lead the management of controlled drugs, including licensing, reconciliation, stock returns, and liaising with regulatory bodies.
* Support client and regulatory audits, coordinating responses and hosting inspections.
* Maintain and operate the Exceptions and Audits modules within LIMS.
* Collaborate with Laboratory Management to resolve issues related to non-conforming work.
* Deliver quality systems training and assist in the Annual Management Review process.
* Provide QA approvals for procedures, certificates of analysis, technical reports, and deviations.
Requirements:
* Degree in Pharmaceutical Science, Chemistry, Biology, or a related scientific field.
* Over 5 years experience in a quality assurance or compliance role within a regulated industry (GMP, GDP, ISO 9001).
* Strong knowledge of internal audits, CAPAs, supplier management, and regulatory inspections.
* Experience using electronic quality management systems (e.g., LIMS, QMS software).
* Excellent attention to detail, communication, and organizational skills.
What's in It for You?
* Competitive salary & benefits package
* Opportunity to work with a leading pharmaceutical company
* Career development and training opportunities
* A supportive and collaborative team environment