Senior QA Specialist , Stein Harvey Nash IT Recruitment SwitzHELP
|Beschreibung:||Senior QA Specialist|
|Firma:||Harvey Nash IT Recruitment Switz - Firma bewerten|
|Salär:||zu verhandeln CHF - 40 Std/Woche|
For our client in Stein we are looking for a Senior QA Specialist (100%) for a 3-month contract.
Duration: 01/10/2018 to 31/12/2018
Tasks & Responsibilities:
1. Deviation handling
. Coordination of the handling and decision of "critical" and "non-critical" microbiological deviations including approval of the respective microbiological risk assessment of batches involved. Based on this sterile drug product batches are released or rejected.
. Definition and tracking of CAPAs for preventing recurrence of deviations
2. Microbiological QA-Oversight in context with aseptic processing
. Support of production in the (re-)qualification of clean room personnel and operator trainings.
. Supervision and periodic checks of the aseptic working technique during Media Fills or on surprise (VIMOS)
. Assurance and optimization of microbiological routine environmental monitoring and monitoring on surprise (EMOS).
. Microbiological trouble-shooting between PUs and SUs
. Support of PUs regarding qualification/validation of clean rooms, equipment
3. Media Fills
. Assurance and optimization of validation of aseptic processes by Media Fills in time.
. Establishment of the annual Media Fill program
. Approval of MBR (PMX and MES)
. Review and release procedure for all Media Fills
4. Trending of microbiological environmental monitoring
. Perform trend analyses/reports (incl. findings) of the environmental monitoring on a routine basis.
5. Microbiological release of sterile product and water
. Evaluation of relevant product, process and facility related microbiological aspects (BET, sterility and BB tests) as well as the findings of environmental monitoring, water analyses and Media Fills.
. Perform short term planning and tracking of due dates for sterile drug products in collaboration with PUs and SUs.
6. Support, preparation and participation of authority or customer inspections and registration as a biological/microbiological expert
. Cooperation with registration department and authority reviewers in order to optimize the quality of the (re-)registration documents.
. Dealing with authority questions related to the microbiology of sterile products in conformity with international/local legislation and guidelines as well as with company QMs and SOPs.
7. Additional tasks
. Creation, update and approval of SOPs, statements and risk assessments
. Contact to functions outside NTO Aseptics Steriles
. Giving external presentations (eg international congresses).
. Adherence to the safety and ecology guidelines.
. Archiving documents of the team, according to the requirements of the relevant SOP.
- Technical, University/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent.
German: fluently spoken/written
English: fluently spoken/written
Biological/microbiological analytics or diagnostics including aseptic working techniques; quality control/assurance in pharmaceutical industry or biotechnology, especially with regard to sterile products; manufacturing of sterile drug products and aseptic filling.
Are you available immediately, having experience working in pharmaceutical area?
Please send your complete CV in English to (see below) For further details feel free to call me. I am looking forward to receiving your application.
- Informatiker/-in, SystemtechnikHilotec Engineering und Consulti Oberärztin/OberarztKlinik Meissenberg AGPflegefachperson HF/FHKlinik Meissenberg AGPolymerchemiker/-in als Wissenschaftliche-/n, Mitarbeiter/-inSchool of EngineeringResearch Assistant in Blockchain, Cryptocurrencies, Quantitative Finance, 50%School of EngineeringIngenieure (w/m) in Informatik oder InformationstechnologieSchool of EngineeringLeitung Administration, ZollabteilungLagerhäuser Aarau AG