QA IT Specialist
Ref#: CH-FER-0100 / R0008027-SMP
- 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.
- 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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Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.
We manage the entire recruitment process for our client companies - including sourcing of candidates. Candidates are selected based on how well their experience and qualifications match our clients position requirements.
We source and screen thousands of candidates and applications per year and recommend the most qualified candidates to our clients.
If you want to apply for one of the open positions with one of our clients you can do this through this website. Please enter the required data and upload your CV. Our recruitment consultants will screen your application very thoroughly. You will receive via email constant updates on the status of your application. Please apply for each position you are interested in.