Job Reference: J5632242
Updated On: 20/09/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Qualified Person QP to join a leading company based in the South East region, which is commutable from London. As the Qualified Person QP you will be responsible for final batch release ensuring that released products to market, comply with the requirements of the manufacturers licence, marketing authorisations and GMP.
Key Duties and ResponsibilitiesYour duties as the Qualified Person QP 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 act as the Qualified Person in accordance with the duties as defined in the directive 2001/83/EC and code of practice for Qualified Persons. You will verify that all batches have been produced and packaged within GMP guidelines.
3. As the Qualified Person QP, 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 work closely with the wider Quality team and ensure that appropriate audits, self-inspections and spot checks are carried out. You will also support the team with deviation, change controls and CAPA processes.
To be successful in your application to this exciting opportunity as the Qualified Person QP 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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