Associate Principal QA Specialist
Carbon 60
- Slough, England, United Kingdom
- Slough, England, United Kingdom
Über
About the Role
Provide QA review and oversight for various studies and activities. Support a culture of quality and continuous improvement within QC and Development Services. Support Operations to ensure ongoing compliance with GMP. Manage and support GMP issues through QMS processes, site governance and senior QA leadership. Act as a GMP Subject Matter Expert (SME) by implementing, managing and enforcing quality processes on site. Support senior QA leadership in driving continuous improvement and ensuring processes are 'fit for purpose'. Ensure compliance with GMP requirements within Development Services. Maintain compliance with Regulatory Authority expectations, Global Quality Standards and customer requirements.Key Responsibilities
Provide shoulder-to-shoulder review, approval and support for deviations, CAPAs, change controls, investigations and OOS records. Review QA activities for MSAT studies, pilot studies, and Development Services. Review QC activities including method validation, reference standards and stability studies. Manage and escalate critical compliance issues through the QMS. Conduct audit trail reviews. Perform area walkthroughs to identify and resolve non-compliance. Audit raw data, protocols and validation reports for GMP compliance. ...
Sprachkenntnisse
- English
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