Burton upon Trent
+44 (0)151 666 8956
about 1 year ago
My client is a leading Chemical and Pharmaceutical Manufacturing business based within commutable distance of Burton upon Trent. Following a recent promotion, we have been engaged on an exclusive business to support them in recruiting a Senior Validation Analyst to join the business on a permanent basis.
The primary remit of leading all Validation, Cleaning, Equipment, Process and continuous improvement projects, this key role will manage a team of two to ensure ongoing high performance across the Validation and QA function.
Duties will include;
- Work and self-track against Validation Plans and company projects.
- To maintain the Site Validation Master Plan (VMP) and site master file.
- To oversee validation activities to ensure compliance and adherence to schedules and customer requirements.
- To produce and execute Protocols and Reports for critical cleaning procedures, computerised systems, equipment, processes and utilities.
- Responsible for interpreting results of validation test work in relation to “Acceptable Criteria” and for appropriate follow up / documentation.
- Conduct validation tests with minimal impact on operations.
- Liaise with other departments / teams in order to execute and report on validation protocol outcomes.
- To maintain the validation status of critical cleaning procedures, computerised systems, equipment, processes and utilities.
- Where necessary assist with the generation and maintenance of TA.
- Review and where necessary approve change control and BMR / BPR Modifications requests.
- To check and approve validation documentation for use in validation activities
- Timely investigation of NCRs including root cause analysis and risk classification - Liaison with QA and or QP on NCR close out.
- Guidance / generation of appropriate CAPA
- Manage and ensure SOP’s and WI’s for associated tasks are maintained.
- To take part in audits or inspections where required.
- To assist the Quality Assurance and Systems Manager in her duties and provide cover, where appropriate, during periods of absence.
- To maintain quality KPIs providing management with summary and review reports of the validation performance.
To apply, please forward your application for immediate consideration.
Unless otherwise stated, all contract rates stated are on a Limited Company basis.
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