LSC have a great contract opportunity for an Operations Quality Notifications and Investigations Specialist to join a leading biotech company based in Meath.
ABOUT THE PROJECT - KEY RESPONSIBILITIES: Author Quality Notifications: Take full ownership of drafting, reviewing, and finalizing Quality Notifications, ensuring clarity, accuracy, and compliance with regulatory requirements.
Initiate and maintain quality related metrics related to Quality Notifications ensuring effective communication and follow up of the same.
Quality Metrics: Ensure that Quality notifications (including CAPAs, Investigations and incidents) meet our metrics for raised on time and closed on time, while maintaining a high standard of technical writing and compliance.
Incident Reporting: Solely manage the authoring of incident reports, documenting quality issues and ensuring timely submission for review and approval.
Investigations Documentation: Lead the authoring of comprehensive investigation reports, detailing findings, root cause analyses, and corrective actions.
Approval Process Management: Navigate the approval process for all authored documents, collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
Quality Risk Assessments: Participate in Quality Risk Assessments as needed, providing insights and documentation to support the evaluation of quality risks.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.?
2 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).?
Position level will scale with experience level of candidate.?
Strong technical writing capability and previous experience authoring reports and investigations in a GMP environment Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa.
We regret that we are unable to provide visa sponsorship currently.
Thank you for your understanding.
Apply via this advert or contact Adam Murphy at if you have any more questions about this opportunity!
Skills: Deviations Investigations CAPA Technical Writing