MAIN DUTIES AND RESPONSIBILITIES
QA Compliance Officer, supported by the Senior Compliance Officer, will be responsible for:
• Ensuring all work complies with guidance set forth in EU and US FDA GMP regulations governing the manufacture, storage and distribution of medicinal products;
• Internal and external (supplier) audits including organising, planning, performing, reporting and review of evidence;
• Raising, investigating and closing out CAPAs;
• Ensuring supplier questionnaires are satisfactorily completed on time by key manufacturers and suppliers;
• Liaising with suppliers to obtain relevant information for their approval to provide key materials and services to the company;
• Approval of GMP monographs;
• Producing technical agreements for the supply of goods and services from critical suppliers;
• Initiate and progress supplier complaints;
• Maintain the supplier monitoring database and associated spreadsheets for tracking;
• Assisting QA overview of manufacturing and testing areas;
• Providing input to KPI reports for the team;
• Undertaking relevant training
• Undertaking work in accordance with the company health and safety policies and procedures.