Job Description

The Quality Assurance auditor reports to Quality Manager / Supervisor. The job holder will carry out the assigned tasks with competence and to undertake any other reasonable duties which are assigned by Quality Assurance Management.

To conduct in -process and product quality audits across Operations areas to ensure compliance to the Quality Management System, GMP or GLP Regulatory Standards, relevant Standard Operating Procedure (SOP), and customer specification. Constantly work within Operational departments to reduce the risk of quality findings.

The operational activities will include (but are not limited to)

• Ensure duties are carried out according to the principles of GLP and GMP.
• Perform the review /approval of GxP documents, including protocols, technical specification (TS), batch records, workbooks, SOPs, validation protocols, and all other QMS documentation including highly custom and complex assignments.
• Perform data audit and approval of completed manufacturing or testing documentation as they comply with the stated regulatory standard and the approved TS, protocol or SOPs.
• Interacts with other departments to ensure compliance with internal procedures
• Attends and/or cross- functional meetings as a QA representative
• Trains other QA personnel in areas of expertise
• May be SME in complex area of QA
• May be relied upon to set up new or revise existing quality systems
• Perform internal audits as required
• Leads/Participates in projects , as assigned
• Normally receives little to no instruction on routine work and general instructions on new assignments.
• Demonstrates verifiable turnaround times
• Support the operating and maintaining the systems required to perform the core site activities of the Quality Management Systems
• Can act as QA to review and close Events/CAPA
• May have direct interaction with client and/or regulators

Required Knowledge, Skills, and Abilities

Must have as minimum Degree or equivalent in Biological Science or Quality Management. A minimum of two years experience in QA or related field within GXP. The ideal candidate will have experience of working within a laboratory environment. Previous experience of working within quality driven systems and/or a regulated environment. (GLP/GMP). Highly motivated, self-starter demonstrating ability to use initiative with respect to scheduled work activities. Ability to plan and organize own workload to ensure all deadlines are met or exceeded. Excellent attention to detail is essential. Ability to work in a fast paced and changing environment. Excellent oral and written communication skills.