QC Lab Technician Physico-Chemical

仕事内容

My main tasks will be...

• Ensure analysis deadline according to priorities (Organization and planning)
• Ensure proper laboratory documentation associated with testing and investigations in areas of assigned responsibility according to established procedures and regulatory requirements
• Analyze, evaluate and interpret data
• Write and/or review quality documentation as SOPs, Equipment qualification documents (QPP, URS, RA, IQ/OQ/PQ, QP), Method Transfer & Validation/Verification (Validation/Transfer protocol and report)
• Support the implementation of new methods and equipment/instrumentation by performing required testing in support of development, transfer, validations, qualifications, or suitability testing
• Ensure Stability studies: write of stability protocols / reports.
• Review analysis performed in quality control laboratories or externally which are under the responsibility of quality control
• Investigates and documents errors, out-of-specification analyses, deviations and change request according to established procedures and regulatory requirements
• Ensure the qualification status of lab equipment and if necessary, participate to the qualification activities
• Support QC colleagues in case of issues
• Advise employees on technical issues (Production, Quality Assurance…)
• Ensure the function of the LIMS: creation of working-sheets, specifications, methods. Ensure the sample entry. Ensure equipment management
• Maintains a level of technical knowledge and understanding in the assigned area of responsibility, including use of equipment and instrumentation and is able to troubleshoot problems, if they occur
• Ensures all aspects of the laboratory, including but not limited to the instruments / equipment, and the supplies necessary to ensure the proper functioning of the laboratory according to the pharmaceutical Quality Management System (QMS) and the respective health authority regulations. Provide new analytical technologies in respect of our activities
• Ensure laboratory security and ensure that the laboratory remains in compliance with all internal, national, federal, and regulatory procedures
• Participates to regulatory inspections and client audits
• Ensure the archiving of quality control documents (analytical file, logbooks, CoAs, validation / transfer protocols and reports ...)
  

I bring with me...

• Bachelor or master’s degree in pharmacy, microbiology, biotechnology, life science
• More than 3 years of experience in a regulated pharmaceutical quality control and analytical development
• Knowledge of QC laboratory processes and GMP requirements in clinical phase and commercial, is an asset
• Sound scientific expertise in physico-chemical analysis. Knowledge within analytical transfer, method validation, method development for drug substances and drug products.
• Knowledge with Oral Dosage Form is an advantage
• Strong knowledge of analytical methods (Identification, Assay by GC-Headspace, Disintegration, Water Content, Container Closure System …) and Pharmacopeias (EP, USP …)
• Strong knowledge of Validation/Verification & Transfer of analytical Method
• Good knowledge of instrument / equipment qualification
• Ability to prioritize and manage work to critical project timelines in a fast-paced environment
• Very good communication and negotiation skills in English
• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
• Proven leadership skills / lab organization
  

My reasons for choosing Bacthera...

• Innovative and fast growing start-up company with short decision-making processes
• Flexible working hours
• Motivated, agile and multinational team
• Very good pension fund and attractive salary
• Fringe benefits (e.g. Lunch Card, deduction of different brands)
• Interesting and diversified tasks
  

My future working place will be...in VispAbout UsBacthera is a leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.