Qc Lab Expert Raw Materials
vor 1 Tag
**QC Lab Expert Raw Materials (f/m/d) 100%. Basel, CH**:Bacthera is 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.
For our site in **Basel **we are seeking a motivated and talented
**QC Lab Expert Raw Materials (f/m/d) 100%**:
Conducts QC activities in routine physico-chemical analyses of clean utility, raw material, In Process Control, drug substance, drug product, Stability samples and environmental control & monitoring in compliance with established procedures and regulatory requirements..
***Role and Responsibilities**:
- Support the QC Lab manager by managing raw & packaging materials, consumables and single use materials (Review of Raw Material Risk Assessment, need of CRO, Shipment, assists to customers’ meetings, if required)
- Ensure the implementation and/or update of GMP documents regarding Raw & Packaging Materials
- Ensures analysis deadline according to priorities (Organization and planning)
- 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
- Ensures the implementation of new methods and equipment/instrumentation by performing required testing in support of development, transfer, validations, qualifications, or stability testing
- Updates, writes and/or reviews new procedures, methods, protocols, and reports, as requested
- Performs analysis, evaluates, and interprets data, and assisting to resolve issues, if applicable.
- 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.
- Maintains laboratory documentation associated with testing and investigations in areas of assigned responsibility according established procedures and regulatory requirements
- Ensure laboratory security and ensure that the laboratory remains in compliance with all internal, national, federal and regulatory procedures
**Your Profile**:
- Degree in pharmacy, biotechnology, chemistry or life sciences (BSc or MSc)
- 5-6 years of professional experience within the pharmaceutical
- / chemical industry
- Profound knowledge managing, sampling and testing of raw materials
- Understanding of USP / EP / Pharmacopeia
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment
- Self-dependent way of working and taking ownership of assigned tasks
- Knowledge of analytical methods (water content, LC, GC, UV-Vis spectrophotometry, FTIR-spectrophotometry, Raman )
- Very good communication and negotiation skills in German & English
- Service minded, solution oriented, dynamic, flexible and collaborative personality
- Hands-on mentality with a good working spirit
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