Working in close collaboration with the QA team members, with the relevant departments in the company, and under the supervision of the QA Manager, the Senior QA Officer EDMS will be in charge of managing the GxP quality processes, with a focus on GDP, in the running of the site’s Quality Management System. The individual will ensure these processes are kept up-to-date at all times. This will include the maintenance of the various databases (excel sheets or EDMS) and making contact with internal and external stakeholders for the correct processing of the activities. Other duties might be assigned to the Senior Quality Officer in order to assist the other GxP areas of the quality system.

Key Accountabilities:

• SOPs and training
• Change control, deviation, customer complaint, CAPA and audit systems
• Product return process
• Suppliers’ qualification and customers’ verification
• QA document control system (back-up)

Technical/professional expertise required:

• Degree qualified in either pharmaceuticals, biotechnology, or science related subject;
• Clear understanding of Pharmaceutical Industry environment, regulations and constraints;
• Knowledge and experience of working to quality programs such as GMP and GDP, ideally ISO 13485 standard.
• Experience within the pharmaceutical or medical device industry, ideally in a similar position would be an advantage.
• IT skills specifically MS Excel and MS Word, ideally Veeva Vault. Demonstrated autonomy in the daily activity, autonomous, willingness to work in a multicultural environment interpersonal and communication skills (both written and verbal).

Personal specification

• Autonomy
• Good communication and influence skills
• Team spirit oriented
• Build strong relationships with internal customers
• Work with all relevant staff to maintain the smooth running of day to day operations