Senior QA Specialist
RK 3740
Contract – 12 months
Dublin
We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Responsible for product release, ensuring products meet cGMP specifications and regulatory requirements. Provide QA support for technology transfer and improvement of existing manufacturing processes. Contribute to the overall development, implementation and execution of quality systems in support of to ensure complaint, product quality and product safety. Conduct investigations, perform GMP audits, collect data, analyze trends, and prepare management reports as required.
Duties:
• Reviewing batch documentation and product release
• Conducting and participating in manufacturing investigations.
• Reviewing and approving EM deviations
• Developing corrective action plans and monitoring implementation
• Review and approve change control
• Writing and implementing of quality procedures
• Identifying and implementing continual improvements of manufacturing and quality/compliance processes
• Assess current process and systems and recommend improvements to enhance reliability and reduce cycle time
• Analyzing product quality complaints and assisting the external manufacturer to complete complaint investigation
• Participating in quality audits at external manufacturers
• Monitor quality trends, identify issues, recommend and implement appropriate actions to mitigate risk.
• Participate and support escalation process and issue management process
• Support regulatory inspections, manage reporting and monitor follow up on regulatory commitments
• Maintain Quality Agreement and specification changes.
• Responsible for continuous improvement and risk management
Experience and Education:
• A degree is required with a focus in engineering, science or equivalent technical discipline
• 6 years of relevant work experience
• Knowledge of Quality Assurance, Quality Control and Compliance
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.