Junior Specialist / Specialist - QC Compliance - Drug Substance and Drug Product of biosimilars
Gdańsk
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities:
- Review and maintain adherence to QC testing including validation, Specifications, and COA’s
- Oversee any deviations or planned changes in QC and ensure authorization is in accordance with defined systems and relevant authorities
- Confirm that all necessary checks and tests have been performed, including that all additional sampling, inspection, etc. have been initiated due to deviation or planned change
- Inspect all necessary QC documents to ensure they have been completed and endorsed by authorized team members
- Ensure all audits have been carried out as required by the quality Control system
- Account for all factors relevant to the quality of the batch taking necessary action when appropriate
- Maintain knowledge and experience of all technical and scientific progress and changes in quality management relevant to the products including requirements to certify an unfamiliar batch of product type such as a new product range being introduced prior to certification
- Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities
- Ensure adherence to GMPs, GLPs, GCPs, and GDPs
If you have:
- BS or MS in Biotechnology, Biochemistry, Pharmaceutical Sciences or related field
- 1-2 years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment
- Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
- Excellent customer facing capabilities
- Strong verbal and written communication skills essential
We offer:
- Competitive salary
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more