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QA Specialist

Eingestellt von Harvey Nash IT Recruitment Switzerland

Gesuchte Skills: Support, Client

Projektbeschreibung

For our client in Basel we are looking for a QA Specialist for a 13 months contract.
Place: Basel
Period: ASAP- 31.12.2017
Workload: 100%

Main Responsibilities: (Job Purpose: Microbiological quality assurance support for the manufacture and/or release of drug products and starting materials for PharmOps CH including NSLF according to the team specific scope.)

Musts:
* Quality assurance services for PharmOps CH-Solids:
- Support microbiological monitoring of the environment in non-sterile production facilities (air and surfaces) including detergents and disinfectants in time and in accordance to cGMP rules, QMs and SOPs. This task includes the planning of activities, the evaluation and the interpretation as well as the documentation and the reporting of findings; furthermore, it comprises the correct investigation and documentation of deviations as well as the training of production personnel with regard to hygiene.
- Support the qualification/validation of clean rooms and equipment. This activity includes the elaboration of qualification/validation protocols and reports and it comprises troubleshooting in the case of deviations.
- Support the Decision making on "critical" and "non-critical" microbiological deviations and approval of the respective microbiological risk assessments.
- Cooperation with PUs or other QA and QC teams in order to optimize the quality of the processes and the manufactured products as well as to maintain compliance with authority requirements.
- Support preparation of authority inspections and participation as a microbiological expert. - Support authoring and reviewing of SOPs, either microbiological QA/QC-SOPs or production-SOPs
- Training of microbiological analyst and production operators after microbiological deviations or as regular training.

* Quality Assurance services for PharmOps CH-NSLF:
- Support the microbiological qualification/validation activities within the New Solid Launch Facility
- Operate as a microbiological SPOC for all microbiological related activities within the NSLF

* Safety and ecology:
- Supervision of the adherence to the safety and ecology guidelines.

Education: Musts:
(Technical) University/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent.
Nice-to-haves:
M.Sc or Ph.D in general or medical microbiology, biochemistry, pharmacy or equivalent.Experience:
Pharma/other area: Biological/microbiological analytics or diagnostics including growth properties of micro-organisms and culture media preparation; quality control/assurance in pharmaceutical industry or biotechnology, especially with regard to environmental monitoring and cleanliness zones.

For more information, please contact:
Anna Chmura
(see below)

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Harvey Nash IT Recruitment Switzerland