QA IT Specialist

St.-Prex, Switzerland

Posted: 8-Nov-2018

Ref#: CH-FER-0100 / R0008027-SMP


Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.

In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for an:

                                   QA IT Specialist

Your mission:
QA representative for corporate IT applications: maintenance, new developments, trouble-shooting, set-up.
Local coordinator for QA systems and QA oversight for all other systems.

Main Responsibilities:
  • Maintain the quality IT application and modules (ERP, LIMS, electronic Batch record, serialization/aggregation,…) as power user.
  • Support new IT project implementation and any improvements on existing IT systems
  • Ensure qualification/validation status for all quality IT systems. Ensure a periodic re-evaluation of qualification/validation status for all quality IT systems. Define URS, coordinate development and testing, supervise validation testing.
  • Maintain Validation Master Plan regarding IT systems
  • Write and update SOPs and manual for quality IT systems.
  • Organize and implement end user training sessions and first line support.
  • Provide expertise for QA Operation IS project with a focus on processes optimisation and system robustness. FSMP QA representative at global IT meeting and for incident management.
  • Participate in assessment of deviations, CAPA, Change, continuous improvement and trouble shooting related to QA IT systems.
  • Support daily operations with extraction of necessary datas, annual report or investigation. To assist in creation of dashboard of KPI monitoring related to A operation processes.
  • Review electronic batch record design from a QA operation perspective with a risk analysis approach and a strandardization of practices. If required, execute qualification of eBR procedures. On demand, build testing protocol.
  • Active preparation and participation during HA inspections and customer audits.

Required Experience & Competences:
  • IT engineer or equivalent with 3 years of experience in pharmaceutical quality
  • Chemist engineer or QA specialist or equivalent with 5 years’ experience in IT system implementation and/or maintenance
  • Good knowledge of GMP requirements
  • Experience with qualification/ validation of IT systems according to current guidelines.
  • Excellent leadership skills and ability to influence and work across organisational boundaries.
  • Good communication and interpersonal skills
  • Good communication in French and English 

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