#PolpharmaBiologics 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 medicine, offering new hope to patients suffering from serious diseases.
We create a passionate and friendly workplace environment. Join us!
WE ARE LOOKING FOR:
QC Support Team Specialist
Duchnice (pow. warszawski zachodni)
WHAT MAKES US SPECIAL
- International work environment
- Attractive salary
- Cutting-edge technology equipment
- Conferences and trainings around the world
You will take care of:
- Participating in the project related to the developing (start-up) of a new laboratory at the biotechnology plant.
- Participating in the project related to in Quality Control Department;
- Performing maintenance, calibration and qualification of laboratory equipment in accordance with applicable instructions and procedures.
- Participation in the qualification of devices in the QC made by external services.
- Controlling the timeliness and correctness of devices maintenance, repair and qualification work.
- Participation in change control processes regarding laboratory equipment.
- Participation in the development of the GMP system in the Quality Control Laboratory;
- Participation in the investigations, corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality.
- Participation in the preparation of the Quality Control area for GMP audits and certification, responding to audit findings, and remediation of deficiencies.
- Working out of standard procedures, instructions as well as training in them
- Participation in data mapping of QC equipment, assessment of data integrity gaps, and gap remediation.
If you have:
- Higher education, with a specialization in the fields: chemistry, biotechnology, biochemistry or related,
- Experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works, (at least 3 years),
- An additional advantage will be experience in a similar position with knowledge of data integrity,
- Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines,
- Experience in testing of biotechnological products,
- Minimum basic knowledge of statistic techniques,
- Knowledge of MS Office pack;
- Fluent English spoken and written,
- Organizational skills
- Manual and Troubleshooting skills,
- Good communication skills.
Join our Team!
We offer
- Sport Card
- Development programs
- Private healtcare
- Relocation package
- Fruit day
- Integrations events
- Benefit platform
- and more
Apply for the job
Contact us for details
Recruiter
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com
Aleksandra Bufnal
aleksandra.bufnal@PolpharmaBiologics.com