Quality Specialist Opportunity
We are seeking an experienced Quality Specialist to join our team at a leading pharmaceutical company. This is an exciting opportunity to work in a fast-paced, regulated environment where you will play a crucial role in maintaining and improving the Quality Management System (QMS) while ensuring compliance with industry standards.
The Role:
* 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