QC Compliance Senior Specialist
Gdańsk
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Polpharma Biologics 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 medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
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.
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.
Your responsibilities include, but are not limited to:
- Perform investigations of deviations generated with any area of QC , in alignment with global and local procedures This include a strong technical knowledge in either microbiological or Analytical testing .
- Design, author and /or coordinate investigational test plans for hypothesis testing.
- Perform lab investigations for OOS to determine laboratory error and/or open phase 2 investigations, as needed.
- Meet specified timelines for record closer .
- Ability to multi task, prioritize workload, document properly and interpret data accurately.
- Perform SOP review and approval within Quality and for functional area procedures.
- 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).
If you have:
- BS or MS in Biotechnology, Biochemistry, Pharmaceutical Sciences or related field.
- 5+ 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.
- 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.
- Fluency in English.
What we offer:
- Competitive salary.
- Private healthcare.
- Life insurance.
- Pension plan above national standards.
- Relocation package.
- Additional free day.
- and more..