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- 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.
