Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is looking for a Senior QA Associate to provide QA support and oversight for the Irish manufacturing site during facility design and build, including the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).

Job Responsibilities:

• Accountable to provide QA support and oversight to the Irish operations team.
• QA review and approval of quality documentation generate in Irish operations (e.g. including but not limited to Deviations, CAPAs, change controls, logbooks, SOPs, risk assessments, OOO/OOT, temperature logs, etc).
• Generate and prepare quality documents (e.g SOP's and controlled documents e.g. SOPs and Training Material).
• Support a "Quality on the floor" culture and facility walk rounds to maintain a high level of compliance and QA oversight by working closely together with operations ensuring proactive approach to identify potential issues and minimise impact.
• Support the preparation, execution and follow up on regulatory inspections.
• Complete (plan, execute, follow up) self-inspections in a timely manner as per plan.
• Provide QA review for the eQMS system documents.
• Assist in the management and proactively initiate and support continuous improvement of the Quality Management System.
• Deliver GxP compliance training to operational areas.
• Ensure own work complies with GMP, Data integrity and Good Documentation Practice and is undertaken in accordance with applicable quality documents e.g SOP's, BMR's, Protocols, Guidance's etc.
• Ensure own training in undertaken in a timely and GMP compliant manner before the task is undertaken.
• Ensure own KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines. Aid in maintaining QA Operations Team KPIs.

Key Skills:

• Excellent verbal and written communication skills.
• Able to prioritise workload, decisive thinker able to work within agreed timescales
• A high level of attention to detail
• Excellent interpersonal skills.

Requirements:

• Experience of working within a GMP Sterile manufacturing environment.
• Good knowledge of controlled processes and GMP requirements to a QMS.
• Proficient in Microsoft Office and experience in database use and eQMS systems
• Knowledge of GCP and GMP with regards to QMS activities.
• Experience in Competent authority, Regulatory body inspections and audits.
• Experience working in a GxP environment including a minimum 5 years' experience in Compliance and Quality Assurance.
• IT literate, experience managing and operating an electronic QMS.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.