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We are currently looking for a Qualified Person to join a leading company based in the South East area. As the Qualified Person you will be responsible for assisting with the development of the Quality Assurance team to drive compliance of the operational areas to regulatory and company requirements, as well as batch release of sterile products.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
1. You will maintain a thorough understanding of international regulatory guidance, Client, ISO and Corporate requirements, ensuring that all work within the QA department and across site are compliant to these.
2. You will support the Operational Quality Assurance team, providing leadership and guidance to QA Officers and Qualified Persons (QP). You will help in the development, KPI's, targets and objectives of the team, helping drive morale.
3. As the Qualified Person, you will represent the site on product quality matters by having effective communication with regulatory authorities, internal and external customers and agencies.
4.You will also be tasked with Qualified Person (QP) duties, releasing sterile batches.
To be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:
1. Eligibility to act as a Qualified Person as defined in 2001/83/EC and 2001/82/EC
2. Proven industry experience leading and developing Quality functions and teams, within a sterile manufacturing site.
3. A strong working knowledge of the principle and guidelines for GMP regulations. Knowledge of GxP would be advantageous.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.