Senior CSV Quality Assurance Specialist (f/m/d)

Deu - Niedersachsen - Burgwedelsenior

Quality Assurance SpecialistLaboratory & Life Sciences

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Quick Summary

Key Responsibilities

The responsibilities cover the quality aspects of data integrity, GMP computerized systems, master data management and laboratory instrumentation / systems,

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Quality Assurance SpecialistLaboratory & Life Sciences

Job Description

Drive GMP compliance—lead risk‑based CSV, validate systems, ensure inspection readiness. Unlock your potential with us!

Currently we are looking for a Senior CSV QA Specialist (f/m/d) for our site in Burgwedel.

About the Role

~1 min read

A great opportunity is open for a CSV Quality Assurance Specialist to join the global Digital & Data Quality (DDQ) team in Burgwedel, reporting to the Associate Director of DDQ for the Netherlands, Germany and South Africa. In this hands‑on role you will support manufacturing, packaging, laboratory and logistics teams to assess, select and validate computerized systems used in GMP processes, ensuring validation effort matches system complexity and risk. You will provide quality oversight for computerized systems used in support of GMP processes, provide expert Data Integrity (DI) guidance and support inspection readiness. Ideal candidates have a strong DI foundation, Subject Matter Expert (SME) CSV/QA experience in regulated environments in a lead position, strong communication and influencing skills, and a risk‑based approach to validation.

Responsibilities

~1 min read

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Flexible working hours (37.5 hours/week) and an attractive company pension scheme
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Competitive salary package: 13 monthly salaries + holiday pay + target bonus
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30 days holiday entitlement
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Hybrid working model (up to 50 % remote)
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Internal training and promotion opportunities
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International co-operations
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Training on the job
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Contributing your own ideas to the process design
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Insights into the development of medicinal products
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Corporate benefits and free car parking
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Working across borders (20 days per year)
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Paid Parental Time Off (PPTO)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Adaptability, Adaptability, Biopharmaceutical Industry, cGMP Regulations, Change Management, Data Integrity, Data Quality, Deviation Management, Driving Continuous Improvement, Emerging Trends, GMP Compliance, Good Automated Manufacturing Practice (GAMP), Inspection Readiness, Manufacturing Quality Control, Master Data Management (MDM), Pharmaceutical Quality Assurance, Pharmacy Regulation, Product Disposition, Project Management, Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance, Risk Management, Self Motivation {+ 2 more}