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Aktualne oferty pracodawcy

CSV Specialist

Polpharma Biologics

  • Trzy Lipy 3, Gdańsk
    Gdańsk, Pomeranian
  • offer expired 16 days ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular), senior specialist (Senior)
  • full office work, hybrid work
  • remote recruitment

Polpharma Biologics

Trzy Lipy 3

Gdańsk

Your responsibilities

  • Authoring, reviewing and approving validation and qualification documentation and providing guidance to site staff on cGxP requirements for CSV

  • Initiating and performing the GxP risk and impact assessments

  • Taking part in CSV related Deviation, CAPA and change control management

  • Managing 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

  • Collaborating with QA, IT, Engineering, other business units, contractors and vendor resources to ensure successful planning, execution and delivery of validation projects and documentation deliverables

Our requirements

  • Higher directional education (Computer Science, Engineering or technical related fields)

  • Possess 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 2+ years of experience in computerized system validation within a regulated environment including performing 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

  • 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

What we offer

  • Private healthcare;

  • Life insurance;

  • Pension plan above national standards;

  • Relocation package;

  • Additional free day;

  • and more…

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • retirement pension plan

  • coffee / tea

  • extra social benefits

  • pre-paid cards

  • redeployment package

  • employee referral program

  • charity initiatives

  • extra leave

Polpharma Biologics

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!

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