• Contract
  • Suisse Romande
  • Recruiter: Chara Boucherok

The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. 

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

 

 

Main Responsibilities:

·      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

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.