The QA Specialist is responsible for coordination and delivery of QA Systems and Continuous Improvement programmes on site. The role requires identification and implementation of industry best practices including but not limited to processes that support manufacturing, quality control, materials management, validation and quality assurance. The position involves reporting on quality systems and demonstrating ownership, coordination, assessment and continuing improvements for these systems/processes.
Key responsibilities/essential functions include:
- Ensure batches are manufacture comply with GDP, GMP, Regulatory Licences and Marketing authorization
- Provide Quality Assurance expertise to manage Deviations, Change Controls, CAPAs, Complaints, Documentation, Metrics, Global Standards and Policies
- Provide quality oversight for services and operations which are outsourced to CMO's / contract labs
- Review analytical protocols/reports and laboratories data to ensure continued compliance with regulatory guidelines, GMP and GLP
- Provide assessment of existing and proposed equipment & facilities and work practices to ensure continual GMP compliance
- Support preparations for internal/third-party/regulatory inspections, including assisting with the generation of audit reports and responses to observations, proposing recommended conclusions and actions for implementation
- Utilizes knowledge and expertise to improve quality systems, solve problems, provide continuous improvement and execute tasks.
- Drive execution of Quality goals in conjunction with the QA Leadership team in support of the overall business objectives
- Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice
- Ensure Quality Leaders are appraised on all Quality related issues
- Bachelor's degree and 6 years' experience in Pharmaceutical and/or Medical Device Industries
- QP qualification will be considered an advantage
- Strong project management and prioritization skills with proven ability to effectively manage multiple tasks and priorities
· Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization
· Excellent communication and influences skills promoting openness, dialogue and collaboration
· Results orientated individual with a strong ability to effectively facilitate and problem solve issue
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists