QA Compliance officer

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.