Quality Systems & Compliance Manager
Kelly scientific is looking for a Quality Systems & Compliance Manager for a maternity leave for a 6-month period.
Establish, design and oversee Quality Systems and compliance of a pharmaceutical manufacturing site under current GMP and corporate guidelines.
Your tasks / duties
- Follow Corporate Guidelines implementation
- Coordinate a continuous inspection readiness program
- Manage the Supplier Qualification Assurance (QAA, risk assessment) and supplier deviations
- Approve packaging and QC specifications
- Ensure manufacturing site regulation compliance :
- QA documentation review (SOP's protocols, reports...)
- RA requests management
- Manage internal and external audits.
- Lead auditor in self-inspections and external audits.
- Manage CAPAs (workflow, meetings with the concerned functions, KPIs)
- Manage change control
- Lead the Documentation and training systems; Expresso and Success Factor business owner.
- Coordinate and prepare Annual Product Reviews with the objective of verifying the consistency of the process
- Propose a training program and assure a follow up. Organize GMP training for the site
- Manage and Lead the risk analysis
- Perform audit trail review of GMP systems
Monitoring and Communication
- Establish Compilations, trending of GMP data and Key Performance Indicators (KPI)
- Diligently report to head of Quality Unit any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise
- Enssure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality
- Backup for quality documentation management and issuance of batch record
- Backup for compliance approval of QC lab documentation (SOP, specifications, revision analytical dossier QCA & QCM, Analytical method validation documents, stability documents, LIMS modification)
- Backup in due date extension for CAPA and Change control
- Scientific university degree, Master or Bachelor
- At least 4 years of experience in pharmaceutical industry
- Strong Knowledge of GDP/GMP regulations
- Fluent in English and French, both written and spoken
Your contact at Kelly Scientific
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