Lead QA processes in the software factory of Blue Technology, focusing on quality and automation. Collaborate with teams to ensure excellence in deliverables and continuous improvement.
About the role
- Quality Assurance Analyst ensuring GDP and GMP compliance for Omega Pharma Limited. Managing quality systems and acting as RPi delegate for product release.
Responsibilities
- Supporting GDP compliance of Omega Pharma Limited in accordance with the general conditions of the Wholesale Distribution Authorisation (WDA)
- Supporting GMP compliance of Omega Pharma Limited in accordance with the general Conditions of the Manufacturing and Import Authorisation (MIA)
- Supporting quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements
- Acting as an RPi delegate, releasing medicinal products to the market for OPL
- Ensuring product is safe for patients and any investigations are completed using risk-based processes
- Supporting quality systems on site such for the raising of Change Controls, Deviations, CAPAs as required, writing SOPs
- Acting as Quality Lead on business projects
- Overseeing routine + ad hoc rework processes, approving BOMs and managing FSDU/Display Pack Projects
- Managing the Periodic Quality Review programme, preparing the OPL QA reviews and ensuring schedule adherence
- Supplier and Customer qualification and maintenance including annual bona tides and monthly GMDP compliance checks
- Participation in self-inspections, internal and regulatory audits and ensuring necessary corrective actions are put in place
Requirements
- Scientific University Degree or equivalent
- Minimum of 5 years’ experience in a GDP Quality Assurance Role in the Pharmaceutical Industry
- Good understanding of EU GDP/GMP
- Ability to maintain high quality documentation, manage data sources and interpret data for key Performance Indicators to judge the operational state of processes
- Work independently on QMS elements they are responsible - knowing when to escalate appropriately any issues.
- Experience using electronic documentation systems e.g., Trackwise, SAP
- Comprehensive understanding of GMP, GDP, regulatory (UK Human Medicines, MHRA) and broader EU / PICS/ISO requirements for pharmaceuticals, cosmetics, biocides, food supplements & medical devices together with experience direct experience of dealing with regulatory agencies on quality and compliance matters.
- Thorough knowledge of technical and commercial requirements of the business associated with the Quality units' activities, role and resource.
- Acts as consulting expert in the quality field for complex issues associated with quality, technical and regulatory requirements for the business, especially as they relate to GDP.
Benefits
- Competitive salary
- Flexible working hours
- Professional development opportunities
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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