Job Description

Broad Function Execute and maintain CellVec\xe2\x80\x99s Pharmaceutical Quality System to support batch release and GMP auditing, training, validation and qualification and the revalidation / re-qualification program. Review documentation related to CellVec\xe2\x80\x99s GMP operation such as: protocols, batch manufacturing records, SOPs and reports. Trend and report information related to the Pharmaceutical Quality System such as Deviations, Investigations and Corrective and Preventative actions (CAPAs). Prepare statistical data on the site\xe2\x80\x99s quality performance, provide oversight and support continuous improvement.

Principal Responsibilities

• Review documentation in the form of protocols, batch manufacturing records, SOPs, reports and other related documentation that support batch release.
• Administer, review and follow-up internal/external Deviations, Investigations and Corrective and Preventative Actions (CAPAs)
• Write and review SOPs
• Maintain quality metrics to support the continuous monitoring and improvement of CellVec\xe2\x80\x99s quality objectives.
• Responsible to assist with the organisation of Management Review and compiling and reporting on the performance of the quality system.
• Responsible to assist with the organisation of CellVec\xe2\x80\x99s self-inspection system.
• Assist with Supplier Qualification.
• Ensure that customer requirements as documented in Quality Technical Agreement are met.
• Responsible to assist with Product Quality Reviews
• Assist with the timely issue of audit responses and closeout of any audit actions.
• Assist with the timely closure of Change Control and Deviations. Providing assistance, where needed, with the closeout of Deviation Investigations, Root Cause Analyses and Change Control tasks.
• Assist with the Maintenance of the Pharmaceutical Quality System, Quality Manual, Site Master File, Regulatory Filings, Licence maintenance, Quality Risk Management and all other aspects of the Quality System.
• Support batch disposition and product release in a timely manner to meet CellVec\xe2\x80\x99s business targets.
• Actively contribute to a culture of continuous professional development of the quality team keeping up to date with current Quality Standards and regulatory requirements and expectations. Responsible for the knowledge development of the Quality team with regard to product technical manufacturing knowledge and aseptic processing. Ensure information sources, for example through websites, journals and the pharmacopoeias are current and available.
• Ensure that Health and Safety procedures are adhered to at all times and that, as a minimum, all legislative requirements are adhered to.
• Oversee the update and distribution of documents.