Job Reference: JO-2007-65279_1594128678
To manage and drive the site QA systems in conjunction with other Specialists in the QA Product Quality team. To coordinate all QA duties relating to QP batch release and communicate all issues relating to batch release schedule in a timely manner to schedule, manage and deliver the batch release schedule in compliance with Regulatory requirements and GMP guidelines.
- To proactively identify and implement industry best practices including but not limited to internal processes that support manufacturing, quality control, materials management, validation and quality assurance.This role reports directly to the Quality Leader - Packaging/ProductionKey responsibilities/essential functions include:
- Responsible for coordination of the certification of finished product batches to the market as required under the EU Directive 2001/83/EC
- Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing authorization
- Ensure that all necessary production, packaging and quality control documentation has been completed and endorsed by authorized staff
- Maintain oversight of deviations and change controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required
- Proactively participate in the QMR process to ensure that the quality system continues to function effectively and that improvement/remediation actions are taken as required
- Continuous improvement of the quality systems
- - Identifying and building in efficiencies as necessary from a systematic and compliance perspective
- Maintain knowledge and understanding of quality oversight for services and operations which are outsourced to CMO's / contract labs
- Ensure Quality Managers are appraised on all Quality related issues
- Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business
- Responsible for driving the Quality goals in conjunction with the QA Management team in support of the overall business objectives
- Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice
- Significant experience within a regulated environment.
- 3rd level qualification in Science / Engineering discipline
- Eligibility to act as a Qualified Person in line with local and EU directives
- Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization
- Excellent communication and negotiation skills promoting openness, dialogue and collaboration
- Results orientated with a strong ability to effectively troubleshoot and problem solve issues
- Self-starter with good motivational, decision making, exceptional planning skills to deliver stretch targets, project management and communication skills.
- Promote a culture of continuous improvement
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