Computerized Systems Validation Expert

Polpharma Biologics S.A.O firmie

Polpharma Biologics S.A.

Trzy Lipy 3 Building A

Gdańsk

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#PolpharmaBiologics 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!

we are looking for:

Computerized Systems Validation Expert
Gdansk Science & Technology Park, Trzy Lipy 3

WHAT MAKES US SPECIAL

  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world

 

Your daily activities will include:

  • Serving as Subject Matter Expert for GxP software Qualification and Validation utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology
  • Authoring, reviewing and approval of validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV
  • Authoring, reviewing and approval of computer system validation deliverables and presenting them to QA for approval
  • Initiating and leading the GxP risk and impact assessments
  • CSV related Deviation, CAPA and change control management
  • Overseeing the CSV status of technical systems, equipment and production installations
  • Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11, Annex 11 and internal procedures
  • Taking a leadership role and ownership of project related tasks, work under minimal supervision
  • Collaboration with QA, IT, Engineering, 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 (Computer Science, Engineering or technical related fields)
  • Working knowledge of global GxP regulations (21 CFR Part 11, Data Integrity, Annex 11 & GAMP5)
  • Knowledge and understanding of latest industry data integrity trends, lifecycle management of computerized systems (e.g. alarm management, incident- and error management , periodic reviews)
  • Minimum 7+ years of experience in computerized system validation within a regulated environment including leading a risk based end to end systems validation
  • Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure
  • Strong change control, gap, root cause analysis experience
  • Experience in creation/maintenance & implementation of SOPs
  • Fluent English
  • Flexibility, communication skills, teamwork spirit

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more

Why you should work with us

Contact us
for details

Recruiter
Aleksandra Bufnal
[email protected]
#PolpharmaBiologics 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!
Computerized Systems Validation Expert
Gdansk Science & Technology Park, Trzy Lipy 3

WHAT MAKES US SPECIAL

  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world

 

Your daily activities will include:

  • Serving as Subject Matter Expert for GxP software Qualification and Validation utilizing the Good Automated Manufacturing Practices (GAMP) life cycle methodology
  • Authoring, reviewing and approval of validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV
  • Authoring, reviewing and approval of computer system validation deliverables and presenting them to QA for approval
  • Initiating and leading the GxP risk and impact assessments
  • CSV related Deviation, CAPA and change control management
  • Overseeing the CSV status of technical systems, equipment and production installations
  • Conducting activities in accordance with the applicable cGMP, FDA CFR 21 Part 11, Annex 11 and internal procedures
  • Taking a leadership role and ownership of project related tasks, work under minimal supervision
  • Collaboration with QA, IT, Engineering, 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 (Computer Science, Engineering or technical related fields)
  • Working knowledge of global GxP regulations (21 CFR Part 11, Data Integrity, Annex 11 & GAMP5)
  • Knowledge and understanding of latest industry data integrity trends, lifecycle management of computerized systems (e.g. alarm management, incident- and error management , periodic reviews)
  • Minimum 7+ years of experience in computerized system validation within a regulated environment including leading a risk based end to end systems validation
  • Ability to recognize and solve problems independently, good organization and presentation skills, ability to work efficiently under time pressure
  • Strong change control, gap, root cause analysis experience
  • Experience in creation/maintenance & implementation of SOPs
  • Fluent English
  • Flexibility, communication skills, teamwork spirit

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more

Contact us
for details

Recruiter
Aleksandra Bufnal
[email protected]

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