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Senior QA – URS review & C&Q (M/W/D)
Tasks:
Conduct detailed QA compliance reviews of URS and related project documentation.
Support C&Q activities for equipment, utilities, and facilities.
Review and approve GMP-relevant qualification documents, including: Risk Assessments, DQ/IQ/OQ/PQ, Traceability Matrices, Summary Reports
Ensure documentation and qualification activities comply with: EU GMP Annex 15, FDA 21 CFR Part 210/211, ISPE Baseline Guides, GAMP 5 principles, Internal QA procedures and quality standards
Work with engineering, validation, and QA teams to resolve compliance issues.
Identify compliance gaps and support the implementation of corrective and preventive actions (CAPA).
Support document review and approval workflows in Kneat GX.
Participate in audits, inspections, and project meetings as needed.
Provide expert guidance on QA and compliance best practices throughout the project lifecycle.
Qualifications:
Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmacy, Biotechnology, or a related field.
Minimum of 10 years of experience in QA, Validation, and C&Q.
Strong hands-on experience reviewing URS documents.
In-depth knowledge of GMP regulations and qualification requirements.
Proven experience reviewing and approving qualification documentation.
Experience preferred with Kneat GX.
Excellent analytical and problem-solving skills.
Strong communication and stakeholder management abilities.
Fluency in both German and English (written and spoken).
Conditions:
Start: ASAP
Duration: 6 months
Workload: Full-time
Location: 4 days onsite (Stein) – 1 day remote
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