Quality Control Physico-Chemical Expert
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!
The main responsibility will Planning, execution, reporting, verifying the correctness of analytical tests commissioned to the Physico-Chemical Team Implementing new methods under transfer, validation and verification of analytical methods. Carring out and evaluation of QMS documentation. Implementation of tasks related to the quality projects.
Your responsibilities include, but are not limited to:
- Building of a pharmaceutical quality system in scope of Phys-Chem Team, qualification of control and measurement equipment, preparation for GMP audits;
- Timeliness of analytical work related to the validation of the product manufacturing process/active substance and validation, transfer of methods and the qualification of analytical methods.
- Conducting corrective and preventive actions regarding the results of OOS, OOT and complaints regarding product quality.
- Participation in developing or giving opinions on Instructions and Procedures, including the Operating Instructions for control and measurement equipment.
- Participating in change control processes (eg. by issuing opinions on new tests methods and specifications and their implementation in the team).
- Participation in internal and external audits and implementation of post-audit recommendations.
- Compliance with work discipline, GMP regulations, health and safety and fire protection and applicable instructions, procedures and low regulations.
- Improving efficiency and safety at the workplace. Developing the Lean and 6s culture. Introducing and improving indicators of visualization of performance (KPI) in the team and minimizing costs and losses. Implementation of the initiatives regarding improvements in terms of GMP, organizational and technical as well as GMP and fire safety rules.
- Participation in obtaining contract laboratories for externally commissioned tests.
- Continuous improving knowledge, qualifications and experience.
- Participation in GMP, GLP, OHS and fire training and other specialist trainings related to the scope of the Team's tasks. Training of employees of the Team in the scope of tasks performed, GMP and Health and Safety rules.
- As part of the Phys-Chem Team, coordinating and supervising the processes of transfer, validation, qualification and maintenance of analytical methods
- Checking laboratory documentation from tests in terms of meritorious content and compliance with the requirements of data integrity and GDocP requirements’
- Replacing the Team Manager as part of activities carried out for the OOX results and Invalid Assays based on the functioning system documents;
- Replacing the Team Manager in the field of checking device logbooks // registers in terms of meritorious content and compliance with the requirements of data integrity and GDocP requirements’
- Carrying out deviation and change control processes in the QMS system
- Training and onboarding of new employees to tasks in the Team
- Periodical employee management as part of ongoing quality projects.
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).
- Familiarity with chromatographic techniques.
- Knowledge of regulations and guidelines for good laboratory practice (GLP) and Good manufacturing Practice (GMP) contained in the ICH, FDA, EMEA and national guidelines;
- Basic knowledge of statistical analyses;
- Ability to set priorities and multi-task.
- Ability to independently develop work schedules and operational plans.
What we offer:
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- International work environment.
- Additional free day.
- and more…