Qualification validation engineer

View: 95

Update day: 27-04-2024

Location: Genève Genève GE

Category: Pharmacist / Pharmaceutical representatives

Industry:

Loading ...

Job content

Position:Qualification Engineer

Location: Orbe, VD

Profile: Minimum experience of 3 years in qualification/commissioning - validation

We are looking for a Qualification Engineer to strengthen our team in the canton of Vaud for our client, specialized in pharmaceutical.

Responsibilities :

Cleanroom requalification grade D / grade C
Environmental equipment periodical requalification (dispensing cabinets, laminar flows, biosafety cabinets)
Requalification of thermal rooms/systems, periodical mappings (warehouse, cold rooms, fridges, freezers, incubators, thermostatic chambers, cell banks)
Autoclave loads requalification
QC and analytical equipment requalification (HPLC/UPLC, endotoxin systems, capillary electrophoresis, spectrophotometers, cell counters)
Periodic review of all types of systems (equipment, software)
Support for other C&Q activities linked to system implementation or modification

Profile :

Lead the commissioning/qualification/requalification packages by organizing appropriate meetings, help defining strategies and collaborating with other stakeholders (QA, system owners, maintenance/calibration, automation...)
Write, review and manage associated workflows for C&Q deliverables, including but not limited to: introduction forms, URS, protocols, reports, validation plans and summary reports, risk analysis, traceability matrix, GAMP / data integrity categorisations
execute testings and/or plan and coordinate supplier’s interventions
manage deviations and associated investigations, action plans
support C&Q department for continuous improvement, SOP updates
make regular reporting of the activities

More information : adrien.menard@axepta.com

Branche:

Funktion:

Anstellungsart: Contratto a tempo indeterminato

Loading ...

Click to apply for free candidate

Loading ...

Loading ...

Loading ...