Quality Consultant

at  Russell Tobin

What are we looking for in our Quality Consultant?

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
Recruiter

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