QP- Medical Devices/Pharmaceutical

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My client is a Medical Device and Pharmaceutical company based in Scotland that work on collagen implants and are looking for a QP to help with batch releases for use in clinical trials as well as getting a license from the MHRA for manufacturing license

You will be responsible for;

- Ensuring GMP

- Manage any changes in manufacturing or quality control assessing whether these will impact product quality

- Monitoring regulations, laws and legislation at local level guide the development of new products for approval process

- Monitoring of product issues which occurr during manufacturing of the product and impact analysis per country submissions requirements

- Liaising with commercial teams

Responsibilites include;

- Review and release of IMD batches

- Interact with MHRA re site license for manufacture of the IMD

- Interact with Senior RA and QM on the QMS

Education and must haves;

- Must have 5 years within the field and 2 years at Senior level

- Bachelors degree minimum

- QP eligibility confirmed by a notified body

- Experience in product life cycle and DHF

- Knowledge of Medical devices and CE mark

- Experience with notified bodies- BSI, FDA or MHRA

1-2 days per week

Rate- TBC

All remote working

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales