Quality Consultant

2 weeks ago

Camberley, 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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