Qualified Person

We are currently looking for a QP to join a leading Pharmaceutical company based in the Berkshire area. As the QP, you will be responsible for upholding and improving activities that have a direct and indirect relation to QP certification and batch release, whilst acting as point of contact for these. You will also ensure all relevant GMP training is completed as well as closing out training file audit actions.

Your duties as the QP will be varied, however the key duties and responsibilities are as follows:

1. As QP, you will provide QA support to ensure major and critical compliance issues are dealt with appropriately through QMS processes such as, CAPAs and deviations.

2. You will support regulatory and customer audits in areas of Operation and the relevant processes involved, whilst acting as point of contact for interactions amongst QA and internal client functions, external customers and third parties.

3. To actively manage QMS areas ensuring compliance status and supporting site QA leaders and other QPs to support management, design processes and development of strategy.

4. GMP SME expertise will be provided to help with non- QA functions to enforce a GMP culture within Operations, across the site and you will engage in self-inspection of the site QMS.

To be successful in your application to this exciting opportunity as the QP we are looking to identify the following on your profile and past history:

1. The successful candidate will hold a relevant degree in a Science or QA discipline and QP certification.

2. You will have proven industry experience of MHRA and FDA inspections, auditing, risk management and project management. Also, manufacturing of biological products as a QP with relevant licensing would be essential.

3. A working knowledge and practical experience with previous GXP and QMS process design, implementation, management and utilisation experience as well as the ability to interpret and translate GMP guidelines.


Key Words: MHRA | FDA | GMP | QP | GXP | QMS | Auditing | QA | Pharmaceutical | CAPAs | Deviations | Risk Management |