​What you need to know

Matrix Recruitment Group are currently recruiting for a Quality Specialist for our client, a pharmaceutical biologics company, based in Dublin. 
The Quality Assurance Specialist in collaboration with the Quality Assurance Manager will have responsibility to setup and maintain the quality management system supporting functional areas with the establishment of all elements of the quality system including GMP, GLP and GCP in support of clinical and commercial requirements.

Role is based remotely.

Your new job

• Support the setup and maintenance of the QMS across all functions including GMP, GLP and GCP as required 

• Develop phase appropriate SOPs, policies and procedures working in accordance with relevant Standards and Regulations

• Participate in QMS periodic reviews to monitor performance, effectiveness, continuous improvements and evaluate trends 

• Collaborate with cross functional management to drive process and system improvements and alignment

• Deliver training to various functions including GMP Induction, Annual GMP Training (site and supplier) and Training in QMS processes as required

• Participate in the implementation and maintenance of the document management system

• Review manufacturing and quality control records to ensure compliance with standards and regulations

• Preparation, review and upkeep of product specification files in support of QP batch certification

• Provide quality support on various GMP studies including process and analytical validations, stability studies, risk assessments as required

• Perform quality reviews of CAPAs, OOS, Deviations, Customer Complaints and Change Requests 

• Perform internal and external audits 

• Responsible for drafting & upkeep of Quality & Technical agreements with GxP partners

• Participate in and support risk management activities across all functional areas

• Maintain knowledge of existing and emerging regulations industry related regulations, standards, or guidance documents and market requirement.

What are we looking for?

• Bachelor’s degree in a science area as well as any professional certification

• Prior experience in pharmaceutical/biotechnology industry in a start-up environment

• Knowledge of GMP/ GCP/ICH requirements and inspection readiness. 

• A working knowledge of regulatory requirements that specifically apply for the manufacture and/or testing of Advanced Therapy Medicinal Products (ATMP) products.

• Experience in planning, managing and executing vendor and site audits, auditing key raw material suppliers as to GMP compliance.

• Experience of working with different contract manufacturing companies.

• Experience with continuous improvement or implementing new policies and processes.

• Knowledge of clinical trial regulations and guidelines.

• Ensure all operational processes are compliant with regulations.

• Documentation and data quality review to ensure compliance 

• Responsible for the overall management of Quality Management Systems and ensuring internal and external audits are scheduled and conducted in accordance with regulations.

• Responsible for follow up of audit and issue CAPA's.

• Proficiency with Microsoft Products - Word, Excel, PowerPoint, Project, SharePoint, Teams, Zoom and other virtual platforms.

Apply for this job now via the link.

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