QC Compliance Senior Specialist

Ożarów Mazowiecki, mazowieckie
Stała
Pełny etat

26 dni temu

QC Compliance Senior SpecialistOżarów MazowieckiRozwijaj się z namiPolpharma Biologics 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. Dołącz do nas!Our Quality Control department carries out activities related to process monitoring and cooperation with external partners to ensure the safety and efficacy of our products.
The QC Compliance Senior Specialist position does not involve direct laboratory work but focuses on managing quality processes and supporting the team in compliance and documentation.
We are looking for a candidate to join the team and support quality objectives.Your Responsibilities:

Processing deviations and Corrective and Preventive Actions (CAPA), control of changes and their effectiveness
Analyzing trends in product stability results and other quality Key Performance Indicators (KPIs)
Cooperation with suppliers of reagents and services, including contract testing laboratories
Managing samples and Quality Control documentation
Participation in internal and external audits and inspection readiness preparations
Working with IT systems such as TrackWise (quality management system), SAP (Enterprise Resource Planning system), LIMS (Laboratory Information Management System), and EMS Flexdat
Supporting training processes and building quality culture within the department

Our Expectations:

Higher education, preferably in biotechnology, pharmacy, or related life sciences
At least 5 years of experience in the pharmaceutical or biotechnology industry
Very good command of English, both spoken and written
Knowledge of Good Manufacturing Practice (GMP) requirements
Proficiency in Microsoft Office, especially Excel
Strong communication skills and ability to collaborate with internal teams and external partners

We Offer:

24 days of home office per year
Flexible working hours: single shift Monday to Friday, 7:00-15:00 or 8:00-16:00
Attractive benefits package: medical care, lunch card, subsidy for English language learning, subsidy for professional development (studies/courses/trainings), wide range of internal trainings, holiday allowance, massages
Subsidy for your holiday
Additional day off
Opportunities for professional development and internal promotion
Free employee shuttle bus
Stable employment in a fast-growing biotechnology company

Dlaczego warto do nas dołączyćNapisz, jeżeli chcesz dowiedzieć się więcej career@polpharmabiologics.com

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