QC Analytical Projects Lead
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!
Coordination and implementation of tasks related to projects carried out in Quality Control. Responsibility for contact with external entities in the field of analytical method transfers and substantive support and authorship (documents like example AMT plan and report and related) to the Quality Control teams in carrying out tasks related to transfer of methods, improvement, verification/qualification of analytical methods and validation of methods for intermediate and final products, participation in investigations. Contact person for all analytical topics within the project.
Your responsibilities include, but are not limited to:
- Overseeing and coordinating activities in stability testing, methods verification and validation, method transfer, method monitoring and improvement.
- Participating in project team meetings and other project related meetings representing all analytical aspect of the project.
- Cooperating with external units on project.
- Participation in change control processes in the field of projects.
- Participation in the preparation of project budgets in the Quality Control Department.
- Supporting and troubleshooting activities with analytical knowledge.
- Control and coordination of DEV, Lab investigations, CAPA within the project.
- Preparation of the stability test program in accordance with the regulations.
- Participation in internal and external audits and implementation of post-audit recommendations.
- Participation in developing or reviewing instructions and Procedures.
- Continuous broadening of knowledge, qualifications and experience.
- Compliance with GMP, health, safety, and fire protection regulations.
If you have:
- Higher education, with a specialization in the fields: biotechnology, biology, chemistry or related.
- 5 years of experience of working in an analytical laboratory or quality control laboratory in pharmaceutical or biotech works.
- Knowledge of analytical techniques: classical and instrumental
- Computer skills including use of MS Office package.
- Ability to communicate in spoken and written English.
- Knowledge of EMA guidelines, European Pharmacopoeia monographs, US Pharmacopoeia, GMP regulations and pharmaceutical law topics.
- Well-established analytical knowledge and practical ability to validate analytical methods.
- Knowledge of health and safety and fire protection rules.
- Knowledge of quality systems.
- Ability to present and report results.
- Ability to communicate easily in internal and external areas.
- Ability to set priorities and multi-tasking
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more..
