Job Title: Quality Associate - Global Biopharmaceutical
Contract: 6 months
Location: Bracknell or Dublin based (Hybrid)
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 of any issues/gaps and improvement implementation.
* Support in audits/inspections/self-inspection programme when required.
* Operate the Country Organisation quality activities following SOPs and using documentation/IT systems 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).
* 1-3 years of 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.
* Interpersonal relationships and collaboration.
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