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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