QMS Specialist

Orion Group Life Sciences are currently recruiting a QMS Specialist on behalf of our Multinational Biopharmaceutical Client based in Swords, Dublin on an initial 11-Month contract with potential to extend.

Primary Responsibilities:

• Provide quality support to the project and site, including training and guidance on the interpretation and implementation of Guidelines / Policies and regulatory requirements.
• The main areas of expertise are, but not limited to, specific tasks and roles such as: deviation management, change control management, quality systems management, document / SOP management, GMP training & knowledge management.
• Ensure the health & wellbeing of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs
• Serve as support for metrics management for site deviation management and change control systems.
• Support the review and approval of site deviation and investigations reports.
• Support the site change management process.
• Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Day to day management of Deviation CAPA and Change Control metrics
• Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
• Liaise directly with cross-functional departments to ensure that change control and deviation management system requirements are met.
• Support Regulatory and Compliance Inspections at the site as required.
• Support for management of recalls as required.
• Comply with company Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Build a Quality culture that delivers unconstrained supply, Right First Time to our patients.

Qualification and Experience:

• Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations.
• Experience with new product introductions and/or process qualification/technology transfer.
• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
• 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
• Motivated to be an inspiring member of a high performing team.
• Excellent interpersonal skills: communication, decision making, people influencing skills.
• Ability to interact with multiple stakeholders.
• Desire to continuously learn, improve and develop.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.