LC
Lear CorporationQAD ERP Business Analyst
QAD ERP Business Analyst collaborating with teams to analyze and enhance QAD ERP systems in Ciudad Juárez. Focused on process optimization and supporting operational efficiency.
About the role
- 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
Salary
Not specified
Degree requirement
Location requirements
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