▷ 3 Days Left: Associate Quality Specialist

2 weeks ago

Nenagh, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

Overview

An amazing opportunity has arisen for an Associate Quality Specialist. The role supports day to day QA activities on site. The Quality Specialist participates as a core member of the Process IPT (Integrated Process Team).

Responsibilities

- Participate as functional expert in the cross functional team that manages production right first time at site.
- 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 support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives.
- 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 changes 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.

Qualifications

- Degree or post-graduate qualification in Science, Pharmacy or equivalent.
- Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
- Spray drying experience desirable.
- Knowledge and demonstrated expertise in Lean / Continuous Improvement.
- Experience and knowledge of GMP Requirements for Electronic /paper free operations.
- Experience in High potency manufacturing desirable.
- Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately.
- Team Work: 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.

As a company, we are committed to patient-centric healthcare and strive to find solutions for challenging healthcare needs. We value diverse, talented, and committed people and foster an inclusive environment.

How to apply: If you are ready to invent solutions to meet unmet healthcare needs and drive one of the world’s leading healthcare companies, please apply today.

Additional information: Employee Status: Regular; Relocation: No relocation; VISA Sponsorship: No; Travel Requirements: 10%; Flexible Work Arrangements: Not Applicable; Shift: Not Indicated; Valid Driving License: No; Hazardous Material(s): N/A.

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