Due to our continued global growth we are expanding our production capacities. Therefore we are now looking for our new Senior QA Operations Specialist in Meyrin / Geneva.
In this position you will handle the quality assurance of the day to day production activities in your unit : clean utilities & facilities Reporting to the Head of QA Operations your main tasks will include (approx. 60%). :
Review of environmental monitoring files and handle related OOS / OOT / deviations
Drive gowning and personal, product & waste flow strategy
Define appropriate corrective and preventive actions (CAPAs) and ensure follow-up
Ensure the establishment, review, approval of investigation reports in the production workshop with key stakeholders (manufacturing, maintenance and engineering)
Generate relevant KPIs and continuous & annual review reports (incl. trending)
Review and approve Periodic Qualification protocol / report and Standard Operation Procedures (SOPs) according to changes / improvements in the unit
Ensure that documents contents are aligned with Regulatory CTD file and Qualification / Validation protocols and reports
Represent the unit during Internal and Partners Quality Audits or HA Inspections
Ensure Inspection Readiness with shop floor presence and gemba walk
Act as an unit expert in case of specific support for PQR / Deviation Management / Root Cause Analysis / OOT-OOS
Participate in continuous improvement projects
In addition to be the point of contact for the Quality control QA Operations specialists, you will also be a point of contact for QC and Analytical Development for OOT / OOS handling, equipment life cycle, SOP review and approval (approx.
30%).As a Senior QA Operations Specialist, you will support the Head of QA Operations as a deputy (approx. 10%) :
Act as a role model and advisor for the QA operations team during complex situations (deviations, change control, risk assessment, qualification / validation activities)
Handle key manager activities if required (team meeting, KPI follow-up)
Release / rejection of production intermediates according to quality standards and registered specifications
The ideal candidate holds degree as a Pharmacist or Engineer (pharmaceutical, biotech, chemistry, food industry or similar) in addition to the following skills and experiences :
Minimum of 5 years experience in a similar position (as QA or Expert - on-the-floor / Field background) ideally in the pharmaceutical / biotech industry
Solid knowledge and experience in working with guidelines related to GMP (GXP, ICH, Ph. Eur. ...).
Interest and first experience in people management
Ability to drive Risk analysis and root cause analysis with a solution oriented approach
French and English business fluent
You feel comfortable to work and develop good relations with cross functional stakeholders with your strong communication skills.
You have a strong team spirit and are very organized. You are able to work autonomously with a constructive, critical mindset while keeping your work organized.
Based on your structured approach you have strong decision making skills and you are accountable for them.If this sounds like you, we look forward to your application to us at OM Pharma