- Head of Quality- GMP
- Hands on with the establishing, implementing & maintaining a Quality Management system
- **Pharmacy degree is essential**
- Location: North Surrey
- Expanding Specials company
Alex Dobson is recruiting for an exciting opportunity that is ideal for someone who has extensive experience within the Pharmaceutical Quality industry. This is a hands on role whereby you will be responsible for establishing, implementing & maintaining a Quality Management system covering all aspects of GMP. In addition to this oversee the quality across manufacturing unit, warehouse activities and customer service department.
The company is a manufacturer on unlicensed products for the Pharmaceutical industry supplying hospitals and pharmacies in the UK. Founded in 2001 they are currently undergoing a sustained period expansion, doubling in size over the last few years, following success in particular after entering into new partnerships to supply a major high street chain. Over the last few months they have built brand new laboratories increasing their production capability by five times to meet increased demand. The company aims to be “best in class” across all aspects of their service and the range of unlicensed products they offer. They are able to provide medicines to meet a variety of reasons including formulation and / or presentation, for example taste, allergies or fear of needles. Due to the continued expansion they need to continue the development of their quality systems to meet their changing business needs.
This is an influential role where you will need to not only oversee strategy development with the senior management of company as well as its implementation to ensure the QMS is not just fit for purpose but also meets their changing business needs. This is an influential role where you will have to be visible across the company and operate in a hands on manner to be close to the relevant internal stakeholders to ensure you are successful. An overview of the responsibilities are:
- To ensure all required SOPs (Standard Operating Procedures) are in place and conformed to by:
- Implementing & monitoring all Quality systems to ensure compliance with EU directive 2003/94/EC, which covers products for medicinal use in humans.
- Main point of contact on all Quality matters affecting the organization.
- Coordinating with MHRA, Home Office & Pharmacy inspections and Internal Inspections. Leading regulatory & customer/supplier audits
- Responsible for developing & implementing the regulatory strategy to ensure it meets business objectives and requirements
- Ensure MHRA authorisations are effectively maintained, including Submission of variations. Compliance with MHRA & Home Office licences held by the company
- Sets objectives and parameters to monitor, analyse, report on and improve department performance
- Implementing an audit & self-inspection programme for all GMP departments to meet the specific requirements of EU GMP
- Responsible for managing all aspects of discrepancies, errors, complaints, failures or adverse events. This involves investigations, agreeing to relevant CAPA’s, trending, implementing further training for teams where required
- Responsible for implementing, updating and conducting induction and ongoing training for all company personnel in line with MHRA regulations
For this role you should have the minimum of Pharmacy Degree and extensive senior pharmaceutical related experience. Previous roles held within the Pharmaceutical Quality and Regulatory sector is essential. Extensive experience in Supplier Approval, Planning and Management of all aspects of operations. Knowledge of Specials and Clinical Trials customers (Pharmacists, Dispensing Doctors, clinical staff at hospitals, Buying groups) is favourable.
This is a permanent position.