Quality & Compliance Manager

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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