Quality Manager & Responsible Person

Job Description

Quality Manager & Responsible PersonJob PurposeResponsible for the management and operational performance of the Quality teammates and activities relating to Government Contracts within Movianto UK.The successful candidate will have overarching responsibility for quality management systems implementation and application for government contracts including vaccines and other medicines, pandemic and influenza preparedness and emergency preparedness resilienceresponse.To ensure compliance to the companies Quality Management System and regulatory requirements set out by the MHRA and Home Office as necessary.What you will deliver (responsibilities include):

• Ensuring compliance to Movianto QMS procedures, ISO 9001, ISO 13485 as well as GxP legislation and regulatory requirements
• Defining standards for quality for Government contracts activities, measuring and reporting results to Senior Management
• Ensuring that the Quality Management System (including but not limited to Change Control, deviation, CAPA, self-inspection) is operating consistently and effectively
• Interacting with and hosting inspections from regulatory authorities and liaising with government agencies in all relevant departments as required
• Provide company training on Quality topics (such as Quality Culture, Deviation and CAPA Management, Internal Auditing, Data Integrity) and Gaps
• Incorporating Quality Risk Management and Risk Assessment into all processes
• Ensuring traceability and follow up of recalls
• Ensuring prompt processing of returned goods within set quality parameters
• Ensuring qualification and validation of systems, processes, equipment and facilities
• Ensuring calibration for all quality critical devices is maintained
• Build relationships with clients quality team and provide clear communication with the client while understanding their needs and expectations

Who we are looking for:

• You must be able to work in a team and independently demonstrating a high level of performance and attention to detail
• You are able to work under pressure, in a busy and demanding environment, and to strict deadlines
• You will have the ability to present and communicate with confidence to a wide range of audiences including government representatives and MHRA inspectors/ ISO auditors
• You will be practical with excellent organisational skills and able to prioritise
• You will be aware or root cause analysis and management review techniques
• You will demonstrate excellent cross functional teamwork and collaboration skills

Key Knowledge, essential skills and experience needed:Essential

• Experience of working as a responsible person named on a WDA
• Experience within Pharmaceutical and/or Healthcare Industry (minimum 3 years, preferably 5)
• Good working knowledge of GDP Guidelines
• Experience of Quality Management Systems and Quality Auditing
• Experience of transportation, storage and distribution of pharmaceutical products
• Experience of transportation qualification and validation
• Experience of leading, coaching and managing a team

Desirable

• RP Gold Standard Trained
• Qualified Lead Auditor
• Knowledge of GMP, pharmaceutical manufacturing, clinical trials and Specials
• Knowledge of Computer System Validation Processes

Contract type Full time PermanentLocation: LutterworthSalary £55,000 - £70,000Ref: 137 846