Description:
Barden are delighted to be supporting our rapidly growing Global Pharmaceutical and Healthcare client in their search for a Quality Specialist QMS. This is an initial 12 month Fixed term contract.
ABOUT THE ROLE:
Reporting to the Quality Compliance Manager, The Quality Specialist QMS will be accountable for overseeing adherence to the Quality Management System in accordance with relevant regulations and company guidelines. The primary objective of this role is to mitigate risks by upholding stringent standards of quality and regulatory compliance. This entails offering guidance and supervision in enhancing quality systems, aligning them with evolving business requirements and applicable regulations, all while ensuring the ongoing validation of the electronic Quality Management System (eQMS).
Roles & Responsibilities:
- Review, approve quality records (change controls, deviations, CAPAs, procedures, validation and other quality related documents.
- Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified.
- Quality oversight ensuring compliant operation and maintenance and system administrator of eQMS, liaising with application vendor in resolving issue and annual upgrades.
- Coordinate internal audit program.
- Support and participate in the preparation for regulatory and customer GMP inspections.
- Support the co-ordination of Contract Manufacturing Organization (CMO) change notifications, assess where required and support the management of change within the QMS.
- Conduct GMP training as required, including roll out of Multi-disciplinary cross training and training on the electronic QMS
- Analyze and trend data, generate metrics and prepare reports for the Quality department and management, escalate any product, supplier or system issues found, tracking to resolution.
- Drive continuous improvement of processes to ensure quality is maintained while efficiency is optimized.
- Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business.
- Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business.
- Support cross-training opportunities and skills.
- Provide day-to-day department support activities as necessary to aide completion of project deliverables.