QC Systems Senior Associate Change Control

Orion Group Life Sciences are currently recruiting a QC Systems Senior Associate Change Control on behalf of our Multinational Biopharmaceutical client based in Dun Laoghaire on an initial 12-month contract (with potential to extend).

Quality Control (QC) Systems Senior Associate Change Control is a key member of the QC Systems team. They provide support to the QC function for all activities within the Quality System associated with QC Change Controls. This role will involve leading, coordinating, contributing to and undertaking activities pertaining to QC Change Control records. The role provides technical expertise with a focus on Compliance, Continuous Improvement and Right First Time (RFT). The role represents the QC unit by liaising with internal and external customers. The role may involve carrying out additional work functions that are not described in this specification but are associated with the role.

Key Responsibilities:

• Own and manage Change Controls through their life cycle for QC.
• Ensure timely completion of QC Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
• Ensure flow of communication to stakeholders.
• Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information.
• Monthly Metrics Management and Reporting.
• Participate in cross functional change controls.
• Contribute to success of QC Goals.
• Audit and Inspection preparation and participation.
• Lead continuous improvement activities to achieve standards of operational excellence/
• Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals.
• Apply expertise and critical thinking to independently resolve issues.
• Provide technical guidance.
• Be responsible for specific programs and/or projects.

Qualifications & Experience:

• Hold a third level qualification in a Science related discipline.
• Minimum 4 years' experience in a Biotechnology/Pharmaceutical/GMP environment.
• Knowledge of lab operations, analytical lab techniques, commercialisation, and cGMP.
• Experience using Trackwise/Quality Management Tracking System (QMTS).
• Experience in managing and owning Change Controls would be advantageous.
• Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information.
• Anticipate and prevent potential problems.
• Excellent verbal and written communication skills including technical writing, presentation and facilitation skills.
• Strong ability to lead teams and effectively utilize team resources.
• Ability to evaluate complex compliance issues.
• Ability to work in a fast-paced environment with changing priorities.
• Excellent organizational Skills and Time Management.
• Ability to work under minimal supervision.
• Ability to identify and manage competing priorities.
• Skills in the areas of teamwork, flexibility, coaching and motivating.

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.