QC Compliance Senior Specialist
Ożarów Mazowiecki
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Polpharma 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.
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