- Assure compliance of processes and documentation with cGMP standards;
- Generation, review and maintenance of Quality System documentation and procedures;
- Provision of suggestions and comments, evaluation and approval of changes directly related to the critical systems, manufacture and analytical methods;
- Review of standard operating procedures;
- Review of GMP related documents, such as specifications, methods, validation documents, technology transfer documents, etc.;
- Issue approved hard copy documents to designated departments;
- Creating document status reports as requested by Management;
- Collection of information required for periodical product quality and critical systems reviews;
- Work with all departments as needed to make sure documentation requirements are met.
- University degree in natural sciences (biology, biochemistry, biotechnology, chemistry);
- Previous work experience in quality assurance, quality control or production;
- Work experience in International Company, GMP and regulatory requirements knowledge would be an advantage;
- Very good English language skills (verbal and writing);
- Very good computer skills;
- Ability to work individually or as part of the group on special projects;
- Ability to work on multiple projects and tasks;
- Able (and willing) to shift focus among projects at short notice and under tight time requirements;
- Proactive and diligent.
1300-1900 eur/mon. gross
NORTHWAY ĮMONIŲ GRUPĖ
Northway Biotech is a leading Contract Development and Manufacturing Organization (CDMO) located in Vilnius, Lithuania, EU and Waltham, MA, USA. Extensive expertise in drug substance and drug product development, as well as GMP compliant manufacturing, makes us exceptionally well-versed in all aspects of the biopharmaceutical value chain – from gene to drug manufacturing in microbial and mammalian expressions systems. Our customers appreciate our ability to react rapidly to unexpected project changes, adjusting timelines, and availability of additional capabilities to meet our customers' evolving needs. We are deeply invested in providing high-quality, world-class contract development and manufacturing services with vast flexibility and responsiveness backed by a strong foundation in science and technology innovation.