Praca w Gdańsku i okolicach: QA Process and Cleaning Validation Senior Specialist

QA Process and Cleaning Validation Senior Specialist
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!
Your responsibilities
  • Serving as Subject Mater expert for Cleaning and Process Validation according to cGMP and FDA requirements;
  • Review and approve validation documentation and provide guidance to site staff on cGxP requirements for cleaning and process validation;
  • Performing and approving the GxP risk and impact assessments ;
  • Approving Deviations, CAPAs and Change controls related to Process and Cleaning Validation;
  • Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11 and internal procedures;
  • Collaborate with Production, MS&T, Engineering and other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables.
If you have
  • Higher directional education (Chemistry, Biotechnology or technical related fields);
  • Possess working knowledge of global GxP regulations (GMP, 21 CFR Part 11, Data Integrity);
  • Knowledge and understanding of latest industry data integrity trends, lifecycle management for cleaning and process validation;
  • Minimum 3-5 years of experience in pharmaceutical industry with knowledge about cleaning and process validation;
  • Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure;
  • Strong change control and root cause analysis experience;
  • Experience in creation/maintenance & implementation of SOPs;
  • Must be well-organized and a team player;
  • Must be detail oriented, with strong analytical and problem-solving skills, and to effectively research, troubleshoot, and solve challenging problems involving integrated systems;
  • Fluent English;
  • Flexibility, communication skills, teamwork spirit.
Join our Team!
Why you should work with us
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