Premier Recruitment Group is working in partnership with a well established and international organisation in Dartford to recruit a Quality Assurance Auditor to join their team. This is an exciting, full-time and permanent role.

This role a rotating shift role, one week early 6am-2pm and one week late 2pm-10pm.

Mon-Fri working week.

The candidate must have previous experience in the QA auditing of paperwork.

Job Summary

• Responsible for reviewing batch documentation to ensure compliance with manufacturing standards for products made in company and EMEA.
• Responsible for auditing manufactured and raw material batches to relevant standards
• Responsible for performing live process auditing on the shop floor.

Responsibilities & Duties

• Audit batch documentation packages for compliance prior to release of product for sale including the review and approval of QC results within Oracle.
• Conduct plant and QC inspections to ensure that procedures and practices are adhered to when required.
• Review and generate production batch documentation of RP batches prior to release.
• Correct entry of appropriate data into the Oracle computer system for the release of batches for manufacture and subsequent approval for packing.
• Change status of raw material deliveries in the Oracle system as indicated by completed raw material data packages.
• Liaison with colleagues in other departments, share data and provide QA documents when required.
• Conduct live process audits in line with procedures and schedules
• Maintain FTR & FTQ data for management reporting and analysis.

GENERAL:

• Ensure all tasks are carried out in compliance with company’s ISO, GMP and Health and Safety procedures.
• Promote continuous improvement within the department and provide support to other departments in improvement activities.
• To assist other areas with cover, as and when required, to ensure an efficient service is always provided by QC/QA Auditing department.
• To carry out any duties commensurate with the position
• To attend training courses as required.
• Ensure his/her training record is up to date via Oracle OLM.
• To follow company’s “Guidelines for Excellence”.

ESSENTIALS:

• Experience gained in a pharmaceutical industry
• Experience of working in Quality Assurance or Quality Control environment
• ISO9000, cGLP/GMP, IPEC, HACCP experience

If you think you have the right skills, knowledge and abilities for this position and would like to be considered, please apply or contact directly Tom Kurczab at Premier Recruitment Group.