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Job Title: Quality Associate - Global Biopharmaceutical
Contract: 6 months
Location: Bracknell or Dublin based (Hybrid)
Salary: 37.39 PAYE, 42.89 Umbrella per hour
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
Job Responsibilities:
- 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)
Essential Requirements:
- 1-3 year experience in the pharmaceutical industry, GxP knowledge
- Good level of skills in the use of computer based systems and applications
- 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
- Demonstrate Continuous Learning
- Interpersonal relationships and collaboration
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
