Quality Control Senior Specialist
Duchnice (pow. warszawski zachodni)

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 role

As a Quality Control Expert you will be responsible for implementation of work in the scope of the tasks related to the sample management process: registration, distribution and archiving of analytical samples, samples for stability tests.

Your responsibilities

  • Building of quality control systems for sample management, qualification of control and measurement equipment
  • Samples distribution and aliquoting at QC
  • Archiving samples in QC
  • Supervision of the development of stability study protocols, splitting/distribution of samples for stability studies in QC. Supervision of equipment/rooms necessary to store stability study samples
  • Shipping/receiving samples to/from the contract lab
  • Participation in the implementation and working of the LIMS system and supporting processes
  • Preparation of sampling plans for the production process
  • Perform and document analytical work used in Quality Control in accordance with GMP
  • Preparation of product intermediates, media and buffers specifications
  • Preparation of documentation for registration purposes
  • Monitoring environmental conditions in equipment and rooms
  • Developing, reviewing, approving Instructions, Procedures and other system documents
  • Verifying, updating and checking laboratory documentation (including cleaning logbooks, equipment logbooks, laboratory registers) in electronic and paper versions
  • Initiate/participate in change controls, deviations and ongoing investigations
  • Participation in lab investigations (OOS, OOT, and complaints for product quality) and associated corrective and preventive actions
  • Create, supervise change control process, deviations, investigations and CAPA in TWD system
  • Participation in internal and external audits and implementation of post-audit recommendations
  • Compliance with GMP,DI, health, safety, and fire protection regulations
  • Finding new solutions for better planning and organization of work in the team. Improving efficiency and safety at the workplace. Developing the Lean and 6s culture

If you have

  • Higher education in the field: biotechnology, pharmacy or related
  • 3 years of professional experience in related positions
  • Good knowledge of computer and MS Office.
  • Knowledge of EMA, FDA guidelines, pharmacopoeia monographs, GMP regulations and pharmaceutical law issues
  • Ability to communicate in oral and written English language.
  • Ability to communicate effectively internally within QC and external teams
  • Ability to identify and solve problems independently

 

We offer

  • Private healthcare
  • Life insurance
  • Pension plan above national standards
  • Relocation package
  • Additional free day
  • and moreā€¦
Join our Team!

Why you should work with us

Contact us
[email protected]