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Form of work
SalaryPlease note this is a 12 Month Fixed Term Contract.
Core working hours are between 7am-7pm, Monday - Friday.
The scope of this role is as Quality Assurance Specialist- for clinical labelling activities, with additional responsibilities in the Quality Assurance function
- Review Client and label vendor specifications in accordance with relevant regulatory requirements for assigned projects.
- Review and approve vendor generated label proofs/specifications and other related documents
- Utilise electronic verification software to perform checks on label proofs and routes final label for approval and review.
- Work cross functionally with relevant individuals and project teams.
- Perform specific quality related functions, such as Quality / GMP training, material/product release, validation and quality incident investigation in line with GMP regulations and Client standards.
- Ensure project deliverables and schedules are met, adhere to established standards, which are managed in alignment with the clients project management best practices
- Supports in the investigation of non-conformances and quality incidents. Resolves and documents any deviation or problem pertaining to the audit of documents.
- Reviews and approves documents related to Quality Systems such as Validation protocols/reports, change controls, or other procedural documentation.
- Supports internal and external audits as required.
- Support the Product Development Quality (PDQ) function at Moreton to ensure timely release of Investigational Medicinal Products (IMPs).
- Liaise with responsible Trial Supplies Manager on aspects of clinal supplies packaging and labelling design and study requirements, to resolve any issues
