Job Descriptions

A snapshot of your key responsibilities as a Qualified Person would be:

• Ensure the batch and its manufacture comply with the provisions of the marketing authorisation.
• Ensure manufacture has been carried out in accordance with Good Manufacturing Practice.
• Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
• Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
• Ensure all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes.
• Ensure all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so.
• Ensure all audits have been carried out as required by the quality assurance system.
• Should in addition take into account any other factors of which they are aware which are relevant to the quality of the batch.
• Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
• Ensure that they have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar, for example because a new product range has been introduced, prior to certification

Education and Experience

• Third level qualification in a science discipline with 5 years’ experience in the healthcare/pharmaceutical industry.
• MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC.
• High level of expertise is required to assess day to day quality issues.
• Must become familiar quickly with products and processes in order to assess quality issues.
• Must have good interpersonal skills.
• Must be comfortable with making decisions

Skills

• Interpersonal Skills
• Decision making

Experience

• 5 years