Description
On behalf of my client, one of the largest pharmaceutical companies in the world with headquarters in Basel, Switzerland I am currently recruiting for a:Microbiological QC Support Specialist 100% m/f - 6 months contract with high possibility for an extension
Job Purpose:
Microbiological quality control support for PQ and ramp up of the NSLF (New Solids Launch Facility) for PharmOps CH / SolidsMain
Responsibilities:
- Quality control services for PharmOps CH-Solids / NSLF:
- Support the microbiological qualification/validation activities within the New Solid Launch Facility
- Operate as a microbiological QC SPOC for all microbiological related activities within the NSLF
- Support microbiological quality control services for the qualification and the microbiological and physical/chemical monitoring of clean utilities (water, gas), environmental monitoring in non-sterile production facilities (air and surfaces, including detergents and disinfectants) in accordance to cGMP rules, QMs, SOPs and analytical test procedures.
- This task includes the planning of daily operation, activities, the evaluation and the interpretation as well as the documentation and the reporting of results.
- The analyses will be performed by a contract laboratory; the activity necessitates initial training and audits of and a permanent close collaboration with the contract laboratory. Establishment and maintenance of the necessary "maintenance plans" in SAP for an adequate biological, chemical/physical and microbiological testing of water and gases for pharmaceutical use, incl. drinking water and for the environmental monitoring. Support method transfers from and to the laboratory.
- Support the optimization and validation of analytical methods and equipment as well as cooperation on pharmacopoeial issues.
- Support preparation of authority inspections and to participate as a microbiological expert.
- Cooperation with the team leaders QA and QC of the PU Solids/ NSLF production departments or other quality assurance teams in order to optimize the quality of the processes and the manufactured products as well as to maintain compliance with authority requirements.
- Support authoring and reviewing of SOPs, either microbiological QA/QC-SOPs or production-SOPs
- Safety and ecology:
- Supervision of the adherence to the safety and ecology guidelines.
Education:
- (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.
About me:
I am a specialized recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word format including your hourly rate expectation for immediate consideration.
For any additional information's you can reach me on or at