QA Computerized Systems Validation Expert
Gdańsk
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 role
Your role will be defining computerized systems validation requirements, planning and reporting of computerized systems validation activities and managing of Validation standard operating procedures.
Your responsibilities:
- Deliver the quality assurance of computerized systems program consisting of entire system lifecycle (from URS, through implementation, changes, validation maintenance and periodical review to system retirement) in order to ensure compliance with relevant regulatory requirements and industry guidelines.
- Initiation, review and approval of TrackWise digital actions, deviation, change records, change controls and effectives checks.
- Maintenance of the SOP related to computerized systems validation.
- Review and approval of the Computerized Systems Validation documentation.
- Participation in the meetings related to Validation activities.
- Participation in internal and external audits (Polish and Foreign Health authorities).
- Providing guidance/training to site personnel on cGxP requirements for CSV (FDA CFR 21 Part 11, Annex 11).
If you have:
- Higher directional education (Computer Science, Engineering or related fields).
- 3 - 5 years of experience (or more) in computerized system validation within a regulated environment.
- Experience in process and laboratory equipment validation, EMS/BMS validation and automation systems validation.
- Possess working knowledge of global cGxP regulations (21 CFR Part 11, Data Integrity, Annex 11 & GAMP5).
- Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure.
- Experience in creation/maintenance and implementation of SOP.
- Fluency in English.