Validation Manager
Duchnice
(replacement employment contract)
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:
- Implementation of the reclassification plans for the Company’s critical equipment and systems.
- Ensuring the implementation of the department’s plans.
- Supervision over the course of validation processes.
- Ongoing provision of reports and documentation to the supervisor and/or the appropriate persons to evaluate the process.
- Preparation of the Department for internal and external audits. Participation in all audits in the reporting area.
- Cooperating with all groups, both in the Branch and in the Polpharma Biologics Group.
If you have:
- University degree.
- Knowledge of cGMP and FDA regulations.
- Minimum 5 years of experience in conducting qualification activities (IQ, OQ i PQ).
- Experience in document validation in accordance with GMP regulations.
- Knowledge of Annex 11, Annex 15 and 21 CFR part 11.
- Knowledge of English (B2 minimum).
- People management experience.
- Communication skills, openness to new tasks.
- Excellent organizational and problem-solving skills.