Job Reference: J5634419
Updated On: 08/02/2021
Status: Open to Applications
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Role OverviewWe are currently looking for a Qualified Person to join an ATMP company based in Scotland. 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 ATMP's.
Key Duties and ResponsibilitiesYour 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.
Role RequirementsTo 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.
3. A strong working knowledge of the principle and guidelines for GMP regulations. Knowledge of GxP would be advantageous.
Key Words: Quality Operations | Quality Assurance | Qualified Person | QP | GMP | GXP | QMS | Commercial | IMP | Management | Team | QA | Operational Quality | Audit | Leadership | Technical
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