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The Senior Specialist, Quality Control operation Biologics and supports Commercial quality activities at the Company Gdańsk, Poland.
The successful candidate will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring QC release testing of drug substance and drug product. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, SOP management, and site procedures.
- Ensure deviations are investigated and resolved (within quality as well as functional areas)
- Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions
- Perform SOP review and approval within Quality and for functional area procedures
- Provide guidance and support on equipment qualification, Gap assessment, raw material release activities, environmental monitoring, as well as support of utilities functions
- Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels
- Support, review and approve as needed the change management program (Change Control)
- Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues
- BS or MS in Biotechnology, Biochemistry, Pharmaceutical Sciences or related field
- 8+ years of industrial experience gained in an FDA and EMEA approved pharmaceutical environment
- Knowledge in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, stability, reference standards, specifications, and expiry dating
Additional Skills And Competencies Considered a Strong Asset:
- Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. LIMS, SAP
- Experience in drug product filling and inspection practices
- Fluent in English
- Competitive salary
- Private healthcare
- Life insurance
- Pension plan above national standards
- Relocation package
- Additional free day
- and more
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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.