I am currently recruiting a QA Officer on behalf of my Client, to join the Quality Department within this privately owned pharmaceutical company based outside Carmarthen. The aim of this role is to support the effective implementation and maintenance of the Quality System in compliance with current Good Manufacturing Practice, Good Clinical Practice and the company’s quality strategy.
Job Duties & Responsibilities
- Act as a Quality System Stream Lead, ensuring that:
- the system is maintained in compliance with regulations and standards, and is applicable to the operation and integrated within the PQS;
- clearly written procedures are established and system users are suitably qualified through requirement definition and training provision;
- implementation issues are identified and reported to management;
- performance metrics and KPI are reported, identifying compliance and performance issues/risks, drawing conclusions and making recommendations to management;
- needs for performance improvement are identified and independently interacts with users, championing permanent solutions;
- Maintains current industry knowledge and acts as a Subject Matter Expert.
- Review, check and approve completed batch and associated quality documentation to ensure compliance with GxP prior to certification by the Qualified Person.
- Perform internal and support external audits and complete all follow up actions including report writing.
- Perform and support investigations as they relate to deviations, complaints and adverse events to ensure the identification of true root cause and implementation of SMART and effective Corrective and Preventive Actions (CAPA).
- Support the generation, review and completion of Change Controls, ensuring scope of change is clear and implementation actions are robust and completed in a timely manner.
- Manage and collate information for Product Quality Reviews.
- Support regulatory and customer inspections.
- Provide intra/interdepartmental training as required.
- Prepare, review and approve Standard Operating Procedures and other Quality documents.
- Deputise for the Senior Quality Assurance Officer as required.
Qualifications & Experience
- Degree in a scientific discipline preferable.
- A minimum of one years’ experience in a similar role within the pharmaceutical industry with a sound knowledge of the regulatory requirements.
- Strong IT skills including MS Word, Excel and PowerPoint.
This role will offer the right candidate real job satisfaction and the opportunity to develop their existing skills whilst enjoying the beautiful surrounding areas of West Wales.
If you are interested please click apply!