Key Responsibilities

• Full understanding of GMP requirements in routine operations.
• Awareness and application of Pharmaceutical Regulations in own area.
• Work proactively as part of a team and provide constructive input into resolution of problems impacting on Quality, project, or material.
• Co-ordinate the review and closure of technical customer complaints.
• Participate in compiling and maintaining departmental KPIs, monitor and evaluate trends.
• Support the self-inspection program.
• Support Change control and periodic reviews by authoring and reviewing changes.
• Prepare Reports i.e. technical and trend reports.
• Support regulatory and customer audits.
• Support customer expectations in relation to product shipments and issue resolution.
• Work with other departments to ensure quality systems are maintained.
• Attend meetings related to key responsibilities.
• Ensure adherence with best health and safety practices.

Requirements

• A third level qualification in a science, analytical or pharmaceutical discipline is required.
• 5 years' experience in the pharmaceutical industry. Where appropriate a combination of experience and education will be considered.
• Knowledge and experience of SAP, Trackwise, Veeva, Next Docs or similar quality systems would be beneficial.
• In-depth knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory requirements for pharmaceutical products.
• Competency in the use of computerised systems.
• Good organisational, communication and interpersonal skills.
• Good report writing skills and attention to detail and accuracy.
• Proven track record in your current role is essential.