Quality Consultant

• Title: Quality Consultant
• Contract Length: 12 months.
• Location: Hybrid - Camberly site
• Contract - 12 months

SRG are working with a pharmaceutical company looking for a Quality Consultant to join their Camberly team.

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 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 project plan to ensure effective QMS in 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 Learninng
• 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

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.