QA/QC Manager
About the position
- The QA/QC Manager BBG is in charge of the QA and QC activities of Biotec BetaGlucans and reports to the QA Manager of Lallemand Bio-Ingredients in Europe but is part of the Biotec BetaGlucans team in Tromso. The QA/QC Manager is in charge of maintaining the GMP quality standard and releasing the products after thorough quality control with support of QC technician.
Main functions
The main responisbilitioes for the QA/QC Manager include but are not limited to:
Quality Control
- Maintain the lab and its procedure compliant with cGMP standards;
- Analyze and release products according to cGMP standard;
- Handle Out of Specification according to cGMP standard.
Quality Assurance
- Ensure the lab equipment meets standards with calibration, maintenance etc.;
- Calibrate, validate specific equipment/instruments and processes in production according to validation plan;
- Maintenance of equipment and SOP for production;
- Update on cGMP requirement for API production;
- Management of incidents/deviations and change control related to production and lab;
- Management of customer complaints;
- Maintenance of document management system;
- Internal and external audits (by authorities and customers);
- Supplier qualification and evaluation;
- Product quality reviews and management review;
- Training of personnel.
- List opp arbeidsoppgaver
Required qualifications
Technical skills & Competencies
- MSc in Pharmacy (preferred) Biotechnology, Chemistry, Biochemistry, or related field;
- Extensive knowledge of HACCP, GMP, food safety and food defense principles;
- Experience in the health ingredients field preferably with ingredients made by fermentation.
General Criteria
- Fluent in English and Norwegian (written and spoken).
- Familiar with Microsoft 365 programs.
Personal strengths required
- Precise, rigorous, detail-oriented individual who is comfortable meeting deadlines;
- Ability to work both independently and with a team;
- Aptitudes for communication with authorities, auditors;
- Flexible to work locally in a small company environment and taking on additional tasks as necessary.
We offer
- A collaborative workplace where you will have immediate impact.
- Challenging work in a GMP production unit
- International work environment
- Salary according to qualifications and experience
Questions about the position
ekalda@lallemand.com, Evelin Kalda, QA Manager Europe
Additional information:
- rengstad@lallemand.com, Rolf Engstad, CSO BBG, phone +47 95941542
Om bedriften
About Biotec BetaGlucans
Biotec BetaGlucans AS in Tromsø is a manufacturing unit for yeast derived beta-glucans for the supplement market and pharma industry. The company is a fully owned subsidiary of Lallemand Inc. (www.lallemand.com) which is a privately held Canadian company, founded at the end of the 19th century. Lallemand is specializing in the development, production and marketing of yeasts and bacteria.
Biotec BetaGlcuans is a fully integrated part of Lallemand’s Bio-Ingredients business unit (https://bio-lallemand.com/) having decades of experience as a quality yeast producer for the savory, health, and biotech industries. Lallemand Bio-Ingredients produce a wide range of products including yeast extracts, inactive yeasts and their derivatives for savory food products, enriched mineral and vitamin yeasts for the health supplement and health food markets, and high-grade yeast extracts for the biotech industry.