Packaging Quality Manager (m/f) - Pharmaceutical
Our client is an active company in the healthcare sector based in Geneva.
Your mission as a Packaging Quality Specialist :
- Manage deviations related to packaging area
- Participate to investigations related to production and Quality Control with the concerned functions
- Quality Assurance oversight of packaging and production area
- Review batch records (production and packaging)
- Perform audit trail review of GMP systems.
- Diligently report to head of Quality Unit any Quality Alert/issue and actively participate to resolve significant Quality issues when they arise
- Assure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality Management
- Indirect management of investigation teams and risk analysis team Backup
- Review of Syringes sub-contractor batch Improve, maintain and assure a continuous improvement of the following local Quality Systems to assure the quality of the product:
- Follow up of Potential Quality Incident
- Participate in complaints investigation and Trackwise approval
- Review/approve for issuance of GMP documents related to packaging area
- Review and approve validation/qualification documentation related to packaging area
- Ensure that activities related to the quality in packaging are conform with the company policies and Corporate Quality directives
- Participate in Risk analysis in collaboration with supportive department
- Manage templates/specifications in LIMS and assure their update
- Establish compilations and trending of GMP data Auditor in self-inspections and external audits
- Participate as QA representative to projects related to packaging area.
- Manage for her responsibility area regulatory inspection
As a Packaging Quality Manager you will have to work 4 days/ week including the Saturday and 5 days a week during production shutdown.
Profile:
- Bachelor, University degree in Chemistry, or master’s degree in quality assurance, Quality Control and Validation Method is mandatory
- 3 years’ experience in Quality Assurance environment pharmaceutical industry
- Fluent in English
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