LTO - Quality Specialist
Duration - 12 months Day Rate - 530/day (Inside IR35)Hybrid Working - 2days in the office Location - Welwyn Garden City
LTO - Quality speciaist will be operating in one or more of the following categories:
- With a broad quality background and experience, you will have strong quality knowledge and contribute to foundation and/or squad based work as well as supporting the development of squad/chapter based plans and goals.
- With broad and comprehensive expertise within the Quality environment you will lead foundation work and partner with the business to solve complex quality issues that impact the chapter and/or wider business.
- Contributes to development of squad/chapter based strategic plans and goals.
- Actively contributes to the learning & development of other chapter members.
Processes & Compliance:
- Supports the implementation of GxP QMS requirements, in line with key QMS strategies covering:
- Document Management (including SOP review, drafting and finalisation)
- CAPA Management
- Metric Management
- Service Provider Oversight
- GxP Training compliance
- Quality Risk Management / Annual Product Quality Review
Assists with the preparation and conduct of GxP audits and leads on inspection activities.
Contributes to the preparation, validation and drafting of QMS Quality Reports (on a quarterly basis) and associated preparation for QMS Management Reviews
Performs trends analysis on QMS key performance indicators for review and agreement of LQR/QP
Provides support for any quality, QMS and medical compliance Special Projects
Provides quality, QMS and compliance expertise
Supports maintaining the SOP training grid, ensuring GxP training compliance across the affiliateat all times. Processes & Procedures:
- Undertake Batch Record Review for product release.
- Managing the processing of customer complaints.
- Support BCP activities.
- Owns or supports the local controlled document management process and ensures continued compliance and improvement.
- Ensures alignment between local and global procedural documents with effective implementation and ensure they are uploaded and maintained in the Document Management System.
- Ensures the records management requirements for QMS are established and followed by Affiliate, e.g. COREMAP.
Investigation and root cause analysis of discrepancies.
- Manage deviations to GxP processes in accordance with Organisation global standards.
- Ensure that all applicable affiliate stakeholders are trained and know their responsibilities of the
- Global CAPA processes and their responsibilities as identifiers of potential deviations.
- Ensures change implementation in a compliant manner via the Change Control process.
- Ensures affiliate CAPAs are documented, actioned, tracked, monitored and followed up to timely and effective closure.
- Ensures that the Affiliate Leadership Team, QPs and the QCCL are aware of any at risk and/or overdue or ineffective CAPAs.
For further details, please contact Rudo Urayayi on (phone number removed) or email a copy of your CV to (url removed)
- Drives and implements improvements to quality metrics and identified gaps in collaboration with the business and QCCL.
- Performs trend analysis on data for discussion at LMCO & Affiliate management reviews with input from local SMEs (including QPs, LSR, Local DRA and APT).
- Coordinates and facilitates the collection and review of data for the Affiliate PASSPORT process and ensures appropriate actions are carried out and/or escalated to Local or QCCL.