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, QP 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 onsite)
- 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