To perform Quality Administrative functions in the QA Department to support Milton Park Business. To provide administrative
support for the supplier assurance programme at Milton Park.
Comply with GMP requirements and company rules, policies and procedures.
Vendor set up and ongoing maintenance including approved vendor list
Supporting activities relating to the assurance of new vendors
Supporting activities relating to the assurance of new materials
Issuance of all non project and project documentation to include SOPs, protocols, reports, validations, log books, specifications, SSW, RFM, TO, forms, TC, TCG, C of A, MRs, Laboratory notebooks, ISRs
Administration of change control system
Archiving, to include off site archiving
Filing of all non project and project documentation received into QA
Reconciliation of BMRs
Issuance of BMRs
To plan and prioritize day to day workload in line with the laboratories requirements and adapt where necessary to comply with needs and expectations.
To ensure there is sufficient support in generating and updating documents that are required in the laboratory.
To create or update all specifications as required, forward for approvals and maintain ownership to ensure that documents are implemented promptly.
To create or update all LIMS specifications as required.
To develop LIMS to enable sample logging and data trending.
To be flexible and adaptable in working in different areas within the laboratory if and when required.
To carry out any other tasks which may be required from time to time.
To comply with GMP requirements and company rules, policies and procedures.