Job DescriptionQA Manager
£60,000 - £65,000 - Plus Benefits
My client has an opportunity for a QA Manager, who will be the key decision maker for quality related issues within the business. Reporting to the Head of Quality, you will be responsible for ensuring that the company operates in compliance with UK and International GMP Regulations and Guidelines related to the development, manufacture and testing of drugs.
Key Responsibilities will be:
- Developing, implementing and managing the Quality system and strategy, to ensure it meets the business requirements and customer deliverables.
- Building and managing the Quality Group through recruiting, selecting, orienting, training, assigning, scheduling, coaching high quality employees.
- Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements
- Maintaining MHRA authorisations and coordinating Customer and MHRA audits and inspections
- Maintaining and improving operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
- Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
- Ensuring that there is an audit programme in place covering internal and external activities
- Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events that require documented review and action
- Maintaining an awareness of new and proposed legislation that impacts the business
- Develop and deliver training to the organisation
- Operational responsibility for the manufacturing quality unit to ensure compliance of on-going operations
- Responsible for supplier management.
- Educated to degree level – preferably in a scientific discipline.
- Minimum of 5 years’ experience in a Quality Assurance role in an MHRA regulated (or equivalent) environment.
- Minimum of 3 years’ experience of managing teams with direct line management responsibility.