Quality Compliance Manager

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
  

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales