QA Clean Utilities Validation Specialist
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 include, but are not limited to:
- Deliver the quality assurance of the media validation programme consisting of the entire life cycle of the system.
- Improving knowledge of GMP/FDA standards and guidelines through participation in internal and external training courses and keeping up-to-date with current guidelines and standards in this area.
- Timely realization of tasks assigned by the Manager (Supervisor).
- Preparation, verification of qualification documents, qualification plans, risk analyses, protocols and reports as well as qualification status review.
- Preparation of quality documentation like instructions, procedures etc.
- Participation in FAT and SAT qualification acceptance tests.
- Participation in internal and external audits by presenting the results of the QA Utilities team to internal auditors and Polish and foreign health authorities.
- Deputising the Manager (Supervisor) during his/her absence.
- Cooperating with the Head of Validation and diverse groups of production, scientific, engineering, IT and quality professionals in order to implement and maintain the validated status of Utilities systems.
- Implementation and support of quality records for: changes, deviations, CAPA to ensure business, quality and operational continuity of the company.
- Comply with internal rules and regulations applicable at Organization including taking care of the company's welfare, property and confidentiality of data.
- Additional areas of responsibility may be added as the role may develop along with the development of the organization.
If you have:
- Min. 5 years of direct work experience in the area of responsibility.
- 3 years of experience with Utilities Quality Assurance (pharmaceuticals or biopharmaceuticals, knowledge of GMP/FDA regulations and compliance).
- Very good teamwork and communication sills.
- Communicative English.
- Good organizational and operational effectiveness of work.
- Good computer skills and knowledge of related software, among others (word, excel, power point, Autocad etd).
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more..
Poznaj
Rezon Bio
Dołącz do zespołu ponad 1300 specjalistów produkujących zaawansowane leki biologiczne, które poprawiają jakość życia pacjentów na całym świecie.
Bazując na doświadczeniu Polpharma Biologics, Rezon Bio działa jako partner CDMO (Contract Development and Manufacturing Organization).
Dzięki nowoczesnym centrom biotechnologicznym w Gdańsku i Warszawie-Duchnicach oferujemy szeroki wachlarz możliwości karierowych w obszarach naukowych, technicznych i biznesowych.