Quality Systems
vor 3 Wochen
We are recruiting, on behalf of our client, an experienced QA manager with a focus on Quality System Management and Compliance.
the contract is temporary for 9 months.
At this role, you will establish, design and oversee Quality Systems and compliance in order to assure the Company manufacturing site.
**Responsibilities**:
The mission encompasses involvement in the following main areas according the current pharmaceutical GMP’s (Europe and USA) and Company corporate Quality and HSE Management System:
**_
Compliance:_**
- Improve, maintain and assure a continuous improvement of the local Quality Systems to assure the compliance to current pharmaceutical GMP’s (Europe and USA) and corporate Guidelines
- Follow up on Corporate Guidelines implementation
- Coordinate a continuous inspection readiness program
- Manage the Supplier Qualification Assurance (QAA, risk assessment) and supplier deviations
- Approve QC specifications
- Assure the compliance of the site to regulation:
- QA review for issuance of GMP documents (SOP’s protocols, reports...)
- Main contact for RA requests
**_
Auditing_**
- Manage internal and external audits.
- Lead auditor in self-inspections and vendors audits.
**_
Quality Systems_**
- 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
- Participate to CAPAs follow up
- Participate to change control follow up
- Backup of the Documentation and training systems; Expresso and Success Factor.
**_
Monitoring and Communication_**
- Establishes 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
- Assure a communication flow and collaboration with Operations and other functions to assure a product life-cycle quality
**_Backup_**
- Backup for quality documentation management (Expresso) and issuance of batch record
- Backup of the training systems; Success Factor
**Profile**:
- Technical Degree from a University, Engineering School or equivalent in Life Sciences, (e.g. Pharmacy, Chemistry, engineering or related fields)
- At least 4 years in quality management in pharmaceutical industry
- Experience in leading vendor audits and Self inspection
- Experience with Deviations and CAPA management system (eg: Trackwise), Documentation
Management system, and SAP
- Fluency in English and French is required for the role
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