Our client is an international specialty pharmaceutical company which focuses on the development, manufacturing and marketing of innovative prescription, generics and OTC pharmaceutical products.
Experiencing rapid growth with a diverse product portfolio that spans branded and generic products sold in 30 countries worldwide. They are looking to add a Quality Compliance Manager to the team.
Responsibilities:
* Oversee and help to maintain various Quality Assurance processes ensuring compliant receipt and approval of incoming products from third party contract manufacturers
* Liaise with the manufacturing sites and third party warehouse and distribution providers
* The Quality Compliance Manager will ensure delivery and batch paperwork are provided in a timely manner and good order
* Helping to prepare and approve delivery paperwork to allow final release
* Ensure all SOP's, Technical Agreement's and Quality Documentation are kept up to date and are followed
* Liaise with Regulatory Affairs and respective manufacturing sites to ensure product license variations are managed in a timely manner to ensure ongoing compliance
* Help support ongoing compliance with Medical Device and Food Supplement requirements
* Working with the Quality Team and other functional departments
* The Quality Compliance Manager will be responsible for supplier Management with outsourced partners, third party contract manufacturers as required
* Ensure all GDP aspects for receipt and distribution of products are in order
* Provide audit support as required.
* Regulatory records of all applications submitted to the MHRA and other agencies, artwork co-ordination, complaints for third party contract manufactured products
* Assist in the management, review and filing of the annual product quality reviews, technical agreements and compliance when required, including deviations, change control and complaints
Skills/Qualifications
* Eligible to act as an RP, ability to act as RPi also desirable
* Knowledge of GDP and GMP requirements
* Knowledge and experience with Medical Device
* Ideally degree Level education or equivalent practical experience
On offer
* Salary + Bonus and Benefits Package
* Hybrid Working (3 days on-site)
* Career development in a growing organisation
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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
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