Your mission is to provide QA Validation and Qualification technical support and oversight for the manufacture and supply of Gene Therapy medicinal products.
Job Description
Major Activities:
* Preparation and Maintenance of the Irish site validation plan for MeiraGTx.
* Maintenance and archiving of Validation/Qualification documentation.
* Interface with other departments such as Engineering, QC Laboratories, Operations, Supply Chain and Process Development to ensure that validation project plans are understood and adhered to.
* Clearly communicate and/or provide training in the required validation standard to both the MeiraGTx staff and contractors.
* Review and approve validation, qualification protocols and reports.
* Provide oversight to project-related Deviations.
Responsibilities:
* Ensure that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
* Ensure that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
* Ensure that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state.
Key Job Competencies:
* The individual must have an established track record in delivering robust and regulatory compliant Validation Plans and Protocols.
* Extensive experience of GxP compliance requirements.
* Able to Interact with other departments and personnel across the business both verbally and in writing, demonstrating good interpersonal skills.