Quality Control Compliance Senior Specialist

Polpharma Biologics

Gdańsk

7 dni temu

#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 medicine, offering new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us!

 

 

WE ARE LOOKING FOR:
Quality Control Compliance Senior Specialist
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

In this role you will be responsible for reviews and updates of quality procedures, preparation of proper documentation and ensuring proper course of action in reference to investigations (deviations), corrective and preventive actions and change control management. You will cooperate with domestic and foreign regulatory authorities and participate in preparations of Polpharma Biologics to pharmaceutical inspections and audits.

 

You will take care of:
  • Creation and updates of quality procedures
  • Supporting the process of creation, improvement, standardization of documentation and quality standards of QC at Polpharma Biologics
  • Performing paper and electronic data review to ensure data integrity in the Quality Control
  • Ensuring proper management, compliance and integrity of Quality Control documentation, such as SOPs, protocols, reports, results, methods, specifications etc.
  • Supporting management of CAPA, deviations, change controls, OOS, risk analyses and ensuring if the closing process of quality records is consistent with procedures and deadlines
  • Supporting owners of quality records in reference root cause analyses, investigations related to deviations, OOS researches, risk analyses, defining tasks in reference to Change Controls
  • Ensure implementation of all corrective actions after internal and external audits
  • Participation in processes improvements to increase their efficiency
  • Performing all duties with respect to current GMP requirements and other pharmaceutical regulations
If you have:
  • University degree (Biology, Chemistry, Pharmacy, Biotechnology or related) or 4 years of working experience in the pharmaceutical industry
  • Minimum 5 years of experience in regulated laboratory environment (biotechnological lab will be an advantage)
  • Very good knowledge of GMP and GDP (Good Documentation Practice) rules
  • Ability to solve problems independently
  • Teamwork ability
  • Fluent English, written and spoken
  • Good knowledge of MS Office
  • Good organizational skills
  • Prioritization skills, ability to work towards tight deadlines
  • Analytical thinking ability
Join our Team!
We offer
  • Sport Card
  • Development programs
  • Private healtcare
  • Relocation package
  • Fruit day
  • Integrations events
  • Benefit platform
  • and more
Apply for the job
Contact us for details
Recruiter
Jacek Jaworski
jacek.jaworski@polpharmabiologics.com
Visit us
www.polpharmabiologics.com

Poznaj

Polpharma Biologics

#PolpharmaBiologics to jeden z najnowocześniejszych ośrodków badań i rozwoju oraz produkcji leków biologicznych w Europie. Jesteśmy międzynarodowym zespołem doświadczonych ekspertów oraz ambitnych młodych naukowców posiadających wspólne cele i wartości. Biotechnologia jest naszą pasją, dzięki której wspólnie opracowujemy leki będące nadzieją dla pacjentów cierpiących na ciężkie choroby.
Razem tworzymy przyjazne miejsce pracy, w którym możemy się rozwijać oraz realizować swoje ambicje. Chcielibyśmy, abyś do nas dołączył.

Osoba pracująca w tym zawodzie kontroluje wszystkie lub wybrane fazy procesu produkcyjnego i zapobiega wytwarzaniu towarów złej jakości. W zależności od miejsca pracy zakres czynności kontrolera jakości jest zróżnicowany. Każdy specjalista pracujący w tym zawodzie musi na bieżąco gromadzić i uzupełniać wiedzę o obecnych potrzebach rynku w zakresie wymogów jakościowych stawianych towarom, zgłoszonych patentach i ...
Praca Specjalista ds. Kontroli Jakości