Reference Number: JO-2108-475098
GMP Quality Assurance Associate
Job Type: Contract
We are seeking someone on a 12 month FTC working with a manufacturer of Pharmaceuticals based in Hertfordshire.
- To review batch records, associated documents and to approve intermediate product.
- To support approval of updated master batch records, QC test methods, label text, Supply Strategy Study Documentation and any associated documents.
- To write under supervision, SOPs associated with DQA activities.
- To participate in internal and external audit process and audit schedules.
- To support the preparation and hosting of competent authority inspections.
- To support the processes associated with the development and review of Quality Agreements.
- To raise and support the investigation of deviations and associated CAPAs.
- To raise and support the investigation of customer complaints.
- To review qualification/validation protocols and reports.
- To support testing the effectiveness of DQAs EU product recall procedures on an annual basis.
- To support the implementation of change control activities.
- To generate and maintain Product Specification Files.
- To assist with Eisai supported Investigator Initiated Studies.
- To represent the DQA at clinical study team meetings cross functional meetings.
- To arrange identification testing for imported Investigational Medicinal Products.
- To request batch certification and temperature monitoring data.
- To provide support to other members of the DQA team and EPCS, as appropriate.
- Identify and implement Continuous Improvement opportunities that result in cost savings and more efficient and compliant ways of working.
- To perform any other appropriate duties at the request of the Director, QA GMP, and to deputise for them, when appropriate.