QC Sample Management Expert (LIMS) (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, open minded and experienced person as:
QC Sample Management Expert (LIMS). (f/m/d) 100%
The QC Sample Management Expert (LIMS), a member of the Quality Control, plays an essential role in the daily analytical operations to support the manufacturing of LPBs. He/she will be responsible for the creation, revision, review of master data within the Laboratory Information Management System (LIMS). He/she will also be responsible for providing end-user support for all analytical groups as well as compliance to the client’s global internal policies and procedures. He/she will ensure the GMP level in the laboratory and be responsible for transfer and validation/verification of analytical methods and act as deputy of the Head QC.
- Bachelor or master’s degree in pharmacy, chemistry, biotechnology, life science
- Extensive experience in a regulated pharmaceutical quality control
- Extensive experience with LIMS
- Very good understanding of QC laboratory processes and GMP requirements
- Good knowledge of analytical methods (e.g., physico-chemical and microbiology) and Pharmacopeias (EP, USP)
- 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
- Self-dependent way of working and taking ownership of assigned tasks
Role and Responsibilities
- Act as LIMS Super User. Work in collaboration with the LIMS System Administrator. Perform the end-user training for LIMS.
- Coordinate and execute Change Control actions, to include creations/updates to products, specifications, sampling plans, stability plans, methods, CoAs and other areas in LIMS. Working with QC Managers, QA, as needed, to complete necessary changes, verification of changes and transfer of changes to LIMS system.
- Ensure the creations/updates of consumables, reference standards and equipment, equipment maintenance/qualification plan in LIMS.
- Ensure the creations/updates of environmental controls plan and monitoring of clean utilities / rooms in LIMS.
- Create and maintain LIMS related SOPs, in collaboration with the LIMS System administrator.
- Act as responsible person for samples management within QC:
- Reception of samples
- Labeling of samples
- Preparation of Lab Data Sheet for testing
- Storage and withdraw of stability samples
- Dispatching of samples and Lab Data Sheet
- Responsible of storage, control and withdraw of reference/retain samples
- Ensure analysis deadline according to priorities (Organization and planning) in collaboration with QC Managers.
- Ensure the qualification status of lab equipment and if necessary, participate to the qualification activities.
- Ensure proper laboratory documentation associated with testing, OOS, Change Request, Deviation and CAPA in areas of assigned responsibilities according to established procedures and regulatory requirements.
- Support by writing quality documentation as SOPs, Equipment qualification documents (QPP, URS, RA, IQ/OQ/PQ, QP), Method Transfer & Validation/Verification (Validation/Transfer protocol and report)
- Support QC colleagues in case of issues
- Advise employees on technical issues (Production, Quality Assurance, …)
- Supports the Quality Control department in internal and external audits and requests
- Support QC colleagues in microbiological and Physico-Chemical testing, after the respective training. Analyze, evaluate and interpret data; take a decision in issues, if applicable.
Are you interested to work for an innovative, dynamic and future oriented start-up company? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your full application to Ms. Sandra Gamboni, Global Head of Human Resources; email@example.com.
We are looking forward to welcome you in our offices in the Stücki Business Center in Basel.