About Your New Employer Our Client is a premier biotechnology site based in Dunboyne They are looking for a number of Quality notifications and investigations specialists to join on a 6- 12 month Contract.
You will be working in the deviation writing team.
About Your New Job as a Quality Notifications and Investigation Specialist Take full ownership of drafting, reviewing, and finalizing Quality Notifications, ensuring clarity, accuracy, and compliance with regulatory requirements.
Ensure Quality notifications (including CAPAs, Investigations, and incidents) meet our metrics for raised on time and closed on time, maintaining high standards of technical writing and compliance.
Solely manage the authoring of incident reports, documenting quality issues and ensuring timely submission for review and approval.
Lead the authoring of comprehensive investigation reports, detailing findings, root cause analyses, and corrective actions.
Navigate the approval process for all authored documents, collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
Participate in Quality Risk Assessments as needed, providing insights and documentation to support the evaluation of quality risks.
Contribute to a culture of continuous improvement by identifying opportunities for enhancing documentation processes and quality practices.
Ensure all authored documents meet the necessary compliance standards and are aligned with the Manufacturing Division Quality Management Systems (QMS).
Provide guidance to team members on best practices for documentation and compliance, fostering a culture of quality awareness.
What Skills You Need Quality Notifications and Investigation Specialist Bachelors degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
2+ years in the Biotech Industry (bulk manufacturing of pharmaceutical or biological components).
Strong capability and previous experience authoring reports and investigations in a GMP environment.
Competent in analyzing complex situations and showing practical problem-solving capabilities.
Ability to work independently and within a cross-functional team.
Preferred Experience and Skills Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions.
Experience supporting Regulatory Inspections and Site Internal Audits.
Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
Whats on Offer 6-12 month contract.
Competitive hourly rate Apply now by clicking the Apply Now" button or call me, Elaine McCarthy on .
If the job isnt quite right but you are looking for something similar, please get in touch.
We also have multiple Temp, FTC, and Contract jobs available.
Skills: Quality assurance GMP Manufacturing documentation CAPAS Investigation Quality risk Benefits: See Description