QC Specialist (QC Sample Management Team)
Duchnice
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
- Participating in the project related to the launch of a new laboratory at the plant on biotechnology,
- Developing new and updating existing documentation (instructions, procedures, sampling plans, specifications, certificates, risk assessment),
- Cooperation with internal/external laboratories in the field of analytical samples,
- Participation in internal and external audits and implementation of post-audit recommendations,
- Participation in the implementation and maintenance of the LIMS laboratory management system,
- Sample management (registration, splitting product samples, distribution samples for testing),
- Participation in lab investigations (OOS, OOT, and complaints for product quality) and associated corrective and preventive actions,
If you have
- Higher education, with a specialization in the fields: biotechnology, biology, chemistry or related,
- Experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works, (at least 3 years),
- Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines,
- Fluent English spoken and written,
- Readiness for shift work,
- Organizational skills,
- Openness to changes.