Senior Quality Consultant

3 weeks ago

Camberley Surrey, United Kingdom Russell Tobin Full time

Quality Consultant - Camberley/ Hybrid - 12 month contract
Job Purpose:
• To ensure compliant and efficient execution of a quality project across the UK and Ireland organizations.
• Gap assessment of the QMS for a new entity
• Project planning to ensure effective and compliant integration of the current QMS with to be QMS of the established entity.
• Ownership of the project planning and execution.
• Implementation of project plan to ensure effective QMS in new entity.
• Creation of Quality agreements and contracts

Major Accountabilities:
• Execute elements of the quality management system to support GMDP activities at the Country Organisation and, where required/experienced, support ownership of a quality process or system - this includes understanding and assessment of SOPs, documents, records and metrics related to the systems. Support evaluation any issues/gaps and improvement implementation.
• To ensure compliant and efficient execution of a quality project across the UK and Ireland organizations.
• Gap assessment of the QMS for a new entity
• Project planning to ensure effective and compliant integration of current QMS with to be QMS of the established entity.
• Ownership of the project planning and execution.
• Implementation of the project plan to ensure effective QMS in the new entity.
• Creation of Quality agreements and contracts
• Support in audits/ inspections/ self-inspection programme when required.
• Operate the Country Organisation quality activities following SOP's and using documentation/IT system confidently as required
• Gain knowledge of IT platforms/applications required to operate tasks in those quality systems
• Completion of training in compliance
• Deliver on time for individual actions or commitments – or reschedule appropriately as needed. This includes own training commitments and also actions to support others (e.g. reviews and approvals)

Education & Qualifications:
Life science degree level

Experience:
• 10 years experience in the pharmaceutical industry, GxP knowledge
• Good level of skills in the use of computer based systems and applications

Skills & Knowledge: Strategic/Transitional Skills
• Demonstrate Continuous Learning
• Interpersonal relationships and collaboration
• Operational Excellence - constructively challenge inadequate, inefficient or unnecessary processes and makes suggestions for improvements.
• Being Resilient, Motivated, Managing multiple priorities.
• Organisation skills - self-directed and able to flex to meet peaks in workload. Stays focused on tasks despite disruptions or obstacles

Functional Quality Knowledge/Skills
• Quality System Management
• Understand Regulatory Environment - Knowledge of GMDP and other regulatory requirements relevant for country organisation
• Quality Governance/Compliance - Support preparation for audits and inspections.
• Project management experience for Quality

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