Job Reference: J5631791
Updated On: 27/06/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Computerised System QA Officer to join a leading company based in the Cambridgeshire area. As the Computerised System QA Officer you will be responsible for support the day to day operation and organisation of the company quality systems in order to ensure that products & services used by the business are delivered in line with regulatory guidelines.
Key Duties and ResponsibilitiesYour duties as the Computerised System QA Officer will be varied however the key duties and responsibilities are as follows:
• Requires limited supervision for routine tasks with independent associate companies to provide support for the operation and compliance aspects of local UK and wider European / Global quality systems, in accordance with current GxP’s and departmental SOP’s.
• To assist the maintenance and update of controlled batch documentation in accordance with the company batch document system and regulatory requirements.
• Reviews & updates quality systems documentation as required.
• Assists in providing companywide training & support via the Administration of the ISOtrain training database.
• Assists with GMP and documentation / process failure investigations.
• Participate in the self-inspection programme, carrying out internal audits of other areas as required.
• Undertakes any other reasonable tasks that are requested to help ensure that the highest standards of quality are achieved and maintained within the company’s validated systems.
Role RequirementsTo be successful in your application to this exciting opportunity as the Computerised System QA Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a life science or related technical discipline.
2. Proven industry experience in a Pharmaceutical Organisation ensuring GMP is maintained.
3. A working knowledge and practical experience with Computerised Systems to maintain GMP compliance in a Pharmaceutical setting would be advantageous.
Key Words: Pharmaceuticals | GMP | cGMP | Quality Assurance | QA | Sterile | Licensed Medicines | Quality Management System | Change Control | CAPA's | Deviations | Supplier Management | Compliance | Audits | Specialist | Associate| Quality | GDP | Good Distribution Practice | Vendor Assurance | GXP | GLP | Compliance | Documentation | QA Officer | Senior QA Officer | QA Associate | Documentation | Oracle | Documentum | QMS | Quality Management System | Compliance | MHRA | FDA | EMA
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