Qc Lab Technician Microbiology 100 %

vor 4 Wochen

Visp, Schweiz Bacthera AG Vollzeit

The QC Lab Technician, a member of the Quality Control, plays an essential role in the daily analytical operations to support the manufacturing of LPBs. He/she ensures the execution of physico-chemical tests and analyzes of clean utilities, raw materials, semi-finished / finished products and stability samples according to the procedures and GMPs requirements. He/she will ensure the GMP level in the laboratory and be responsible for transfer and validation of analytical methods. He/she will report to the QC Lab Manager.

**Your Profile**:

- 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 microbiology analysis. Knowledge within analytical transfer, method validation/verification, for clean utilities, drug substances and drug products.
- Knowledge with Oral Dosage Form is an advantage
- Strong knowledge of analytical methods (bioburden, environmental monitoring) and Pharmacopeias (EP, USP)
- Strong knowledge of Validation/Verification 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 German & 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

**Role and Responsibilities**:

- 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 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 can 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...)

**Benefits**:

- Company events
- Company pension
- Company phone
- Employee discount
- Free drinks
- Free or subsidised travel
- Insurance services
- Parental leave
- Work from home

Schedule:

- Monday to Friday

Supplemental pay types:

- Performance bonus

Work Location: One location

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