QA Specialist

Orion Group Life Sciences are currently recruiting a QA Specialist on behalf of our Multinational Biopharmaceutical client based in Cork on an initial 12-month contract (with potential to extend).

The QA Specialist (Gtrack Next Gen Project lead) will be the key point of contact for all Gtrack next Gen project related activities including consulting with Global team and Senior Site management for the duration of the NextGen rollout project. Once the project is complete and the new system is fully stable, they will revert to a QA role within the Quality training and System team.

Duties & Responsibilities:

• Lead or support the NextGen project by performing/coordinating all associated QA related tasks & assigned related tasks as per the project timelines in accordance with site procedures and GMP regulations. Provide QA advice and support as required. Inform QA management of project status, potential quality issues, and significant changes to current site practices.
• May conduct or serve as a lead/coordinator of deviations and CAPA recommendations. Supporting both training and QA systems.
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. These may include the running and design of weekly metrics for Training, On Time Deviations, on time CAPA closure and change controls along with other QA metrics.
• This role may be responsible for the weekly delivery of GMP Induction training and may be required to design and deliver annual GMP Refresher training. Also deliver one to one GMP training when business needs arise.
• Exercises judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations within defined processes.
• Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Acts as a mentor to junior staff in the System/Training team and will need to support a number of new staff as they come up to speed
• Normally receives very little instruction on routine work, general instructions on new assignments.

Key Competencies Required:

• Excellent communication verbal & written skills
• High level of project management skills
• Ability to work effectively in a team environment.
• Ability to effectively communicate with cross-functional peers.
• Ability to prioritise and meet deadlines.
• Advanced technical knowledge of the GTrack systems.

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.