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For one of our clients, a multinational pharmaceutical company operating in more than 60 countries with a pipeline in several therapeutic areas such as oncology and immunology, we are currently looking, on a contract basis, for a Qualification & Validation Specialist with experience in Computerized / Automated Systems (SI/SA).
This is a 1 year contract to based in Aubonne, Switzerland.
Qualification & Validation Specialist – 5015 CBO
· Represent the department at project launch and follow-up meetings
· Establish, write, update and archive the qualification documents according to the procedures in force including:
– Qualification / validation plans (VP)
– Qualification protocols / reports (IQ, OQ, PQ, Hypercare)
– Traceability matrices (TM)
· Schedule, organize and conduct IQ/OQ/PQ/Hypercare qualification tests
· Collaborate with global departments and other sites involved in initial qualifications and various modifications.
· Write and manage deviations according to the system in place during initial qualifications.
· Ensure the maintenance of the service performance indicators.
· Actively participates in the improvement of the qualification processes in place in order to improve efficiency and reduce costs.
Qualifications and Experience:
· Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
· Significant experience in qualification in the pharmaceutical industry
· Good knowledge and significant experience in qualification including:
– CSV/ Data integrity (21 CFR part 11)
– Computerized / Automated Systems (SI/SA): Discoverant (Process Monitoring), Manufacturing Execution System (MES Batch record), Digital Plant Transformation (DPT)
– Equipment : Cap washing machine, autoclave, filling line, freeze dryer, sterilization tunnel, capper, data matrix engraving system, COP/SOP
· Good knowledge of pharmaceutical industry practices related to cGMP qualification/validation
· Knowledge of the main risk analysis tools (FMECA, APR, AMDEC) and continuous improvement tools (Lean-Six Sigma)
· Excellent communication skills and ability to collaborate constructively in partnership with various cross-functional departments
· Proficiency with office tools, spreadsheets, Mango (or equivalent system), Trackwise
· French and English
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