Supplier Qualification Senior Specialist

Polpharma Biologics

Duchnice

2 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:
Supplier Qualification Senior Specialist
Duchnice
WHAT MAKES US SPECIAL
  • International work environment
  • Attractive salary
  • Cutting-edge technology equipment
  • Conferences and trainings around the world
You will take care of:
  • Developing and reviewing Quality System documentation ensuring compliance with internal and legal requirements;
  • Qualification of suppliers using risk-based approach;
  • Ensuring suppliers are compliant to all regulatory and internal requirements and making decisions if supplier is qualified or disqualified as an approved source;
  • Conducting external cGMP or for cause audits of third parties and/or partners to ensure supplier quality-related activities quality system requirements and follow up with suppliers for completion of corrective actions;
  • Maintaining supplier quality agreements;
  • Maintaining the approved supplier list and supplier audit schedule;
  • Active monitoring of supplier quality metrics (supplier performance): number of quality events, delivery failures and other recorded incidents involving the supplier’s failure to meet requirements along with generating regular reports and administering corrective actions as necessary;
  • Providing technical mentorship and resolving quality supply chain issues with suppliers;
  • Mentoring colleagues working with supplier qualification process;
  • Proactive recognition and resolution of quality issues;
  • Recognition of risks and developing contingency plans;
  • Driving continuous improvement and improves efficiency and productivity within the group;
  • Interdisciplinary cooperation between departments, sites and with clients;
  • Participation in internal and external audits.
If you have:
  • University degree (Biology, Chemistry, Pharmacy, Biotechnology or related);
  • 5 years of working experience in the pharmaceutical industry, incl. 3 years in Quality Control and/or Quality Assurance of pharmaceutical products;
  • Experience and knowledge of cGMP and applicable FDA/EMA regulations in the pharmaceutical industry;
  • Knowledge of Quality Management Systems;
  • Auditing competences;
  • Interpersonal skills that promote a collaborative and productive cooperation;
  • Effective and efficient written and oral communication skills;
  • Skills in decision-making, problem solving, planning and organizing, coaching others and analytical thinking;
  • Willingness to travel (domestic and international);
  • Very good knowledge of English.
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

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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 ...
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