Quality Assurance Specialist

Salary: £31,445 – £32,530 per year

We at Orion Group are currently recruiting a Quality Assurance Specialist on behalf of one of our Multinational Biotech Client in Tipperary on an initial 11 month contract.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

Participate as functional expert in the cross functional team that manages production right first time
Review and approve batch, cleaning and testing documentation.
Ensure that all Laboratory Out of Specification (OOS) and Process Deviations are documented, assessed and associated CAPA identified.
Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
Provide guidance on quality requirements to maintain validation status, including participation in Process / Product Risk Assessments.
Provide feedback on re-occurring issues ensuring continuous improvement to systems / processes.
Ensure change controls raised are documented, assessed and completed.
Prepare Annual Process and System Reviews.
Act as lead /team auditor to support the internal GMP walkdown and scheduled audits.
Participate in the generation and communication of quality metrics.
Creation, review and approval of quality procedures as required.

What skills you will need:

In order to excel in this role, you will more than likely have:

Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
Teamwork: Interacts with people effectively. Able and willing to share and receive information.
Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed.
Adaptability: Adapts to changing work environments, work priorities, organizational needs and diverse people.
Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self-direction. Is result orientated.

Degree or post-graduate qualification in Science, Pharmacy or equivalent.
Experience and knowledge of GMP Requirements for Electronic / Paper free operations.
Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
Knowledge and demonstrated expertise in Lean / Continuous Improvement.
Digital proficiency: MS: Teams, Sharepoint, Word, Excel, Powerpoint.
Experience in High Potency manufacturing desirable.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.