QA Manager - Rotherham, United Kingdom - J4 RESOURCING LTD
Description
Quality Manager
The Role
- To ensure that all QA department activity is performed in accordance with defined procedures and activity is appropriately documented
- To ensure that products are released for onward supply following the production process: the release should be timely and accurate and if necessary actions are instigated to rectify any rejections
- To support the business in maintaining compliance to GDP, GMP, and client requirements by:
- Providing QA oversight
- Supporting or hosting MHRA inspections
- Maintaining knowledge of applicable regulations
- Ensuring that all QA department activity is performed in accordance with defined procedures and instructions and where applicable, appropriate records are maintained
- Reporting monthly performance measures, utilising statistics within QPulse
- Ensuring that quality incidents, customer complaints and deviations are appropriately recorded and investigated and that corrective actions are identified and communicated
- Ensuring that all direct reports are trained in GDP and GMP and all relevant procedures
- Ensuring documents are managed, approved and controlled
- Ensuring changes are appropriately documented, reviewed, approved and controlled
- Performing internal and supplier audits
- Maintain the MS in conjunction with the licence holder
- To manage direct reports by:
- Supporting and monitoring direct reports in the continuous development of their skills and ensuring all direct reports are sufficiently trained
- Conducting regular performance reviews and at least once annually conducting a performance appraisal with each direct report.
- Disciplining direct reports in line with the Company Discipline and Grievance Procedure
- Managing departmental holidays, sickness and absence and performing returntowork interviews for every occasion of sickness in line with the Company Procedure
Person Specification
- Thorough knowledge of GDP and GMP regulations
- Knowledge of pharmaceutical regulatory framework within UK
- 3+ years' experience working within a GDP/GMP environment
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