Bracco Suisse SA based in Geneva (Switzerland) is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. Our Manufacturing Site based in Geneva is approved and inspected by the most important Regulatory Agencies (FDA, Swissmedic, etc.) and produce a lyophilized contrast agent exported in several countries.For our manufacturing site based in Geneva (Switzerland) we are looking for a :
Bracco Suisse SA based in Geneva (Switzerland) is a company of the international Bracco Group (www.bracco.com), a leader in contrast agents for medical imaging. Our Manufacturing Site based in Geneva is approved and inspected by the most important Regulatory Agencies (FDA, Swissmedic, etc.) and produce a lyophilized contrast agent exported in several countries.For our manufacturing site based in Geneva (Switzerland) we are looking for a :
Job mission:
To manage all the following tasks and responsibilities according current worldwide current GMP and BRACCO corporate Quality Management System.
You will work 4 days a week including the Saturday and 5 days a week during production shutdown.
Activities:
Batch review
- Review batch records (production and packaging)
- 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:
- QA oversight of packaging and production area
- Manage deviations related to packaging area and participate to investigations related to production and QC with the concerned functions
- Follow up of PQI (Potential Quality Incident),
- Participate in complaints investigation and Trackwise approval
- Review/approve for issuance of GMP documents related to packaging area (SOP’s, specifications, protocols, reports..)
- 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 responsability area regulatory inspection
- Perform audit trail review of GMP systems.
Communication
- Evaluate any signal detection which could have a potential product quality impact
- 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
- backup in production deviation management and complaints management
Qualifications & Skills :
- Bachelor, University degree in Chemistry, or Master degree in Quality Assurance, Quality Control and Validation Method
- Fluency in English (both oral and written)
- Quality commitment, flexibility, initiative, cross functional cooperation behavior
- At least 4 years of experience in QA environment pharmaceutical industry
- Extremely motivated, with rigorous work habits and problem-solving skills
- Excellent team player with a strong ability to communicate
We offer:
- The opportunity to join a well-established and successful company with bright prospects and state-of-the-art manufacturing sites and production facilities
- A great development perspective and the opportunity to bring and utilize your know-how and expertise
- Competitive remuneration packages as well as first class benefits complete this offer
If you recognize yourself in this profile and are looking for a new challenge, send us your complete application (letter & CV) only by mail, through the JOBUP website.