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..