About the Role
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
Drive GMP compliance—lead risk-based CSV, validate systems, ensure inspection readiness. Currently we are looking for a Senior CSV QA Specialist (f/m/d) for our site in Burgwedel.
•Cover the quality aspects of data integrity, GMP computerized systems, master data management and laboratory instrumentation / systems, and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
•Act as a change driver and strategic lead to site processes within the global Quality Management System (QMS) framework.
•Influence the organizational future through review and approval of all quality-related activities, such as policies, procedures, plans, protocols, requirements, reports, deviations and changes, as well as contributing to site inspection readiness.
•Introduce strategic initiatives on site, driving standardisation across the GMP environment for computerized systems and data integrity, and representing DDQ in global governance meetings for data integrity, computerized system validation, master data management and lab instrumentation / systems.
•Promote cGMP and Data Integrity awareness and support a culture of continuous improvement.
•Help develop and maintain training on computerized systems validation, data integrity and internal procedures.
•Work together with the business to resolve regulatory non-conformances for cGMP computerized systems and data integrity in a way that ensures business efficiency and compliance.
•Drive improvements on both a local and global level, based on emerging trends, compliance gaps and system weaknesses.
•Act as a representative for DDQ management in site- and above-site meetings as needed.
Requirements
•Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.
•At least five years of demonstrable experience delivering validated IT solutions or working in an application support role. Lab experience is a plus.
•Knowledge of the latest CSA, Annex 11, Annex 22 and GAMP5 concepts and regulations.
•Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 820, CSA, Annex 11, Annex 22 and GAMP5 concepts and regulations.
•Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
•Strong analytical and problem-solving skills.
•Strong communication and team-work skills add great value to the team's success.
•Timely decision-making and the ability to handle changing priorities.
•Project management skills, a sense of urgency and a track record of delivering quality deliverables.
•Extended experience with deviations, CAPA, change control, master data, qualification/validation, and inspection readiness in a GxP environment.
•Excellent written and spoken German and English skills.
Conditions
•Flexible working hours (37.5 hours/week) and an attractive company pension scheme.
•Competitive salary package: 13 monthly salaries + holiday pay + target bonus.
•30 days holiday entitlement.
•Hybrid working model (up to 50% remote).
•Internal training and promotion opportunities.
•International co-operations.
•Training on the job.
•Contributing your own ideas to the process design.
•Insights into the development of medicinal products.
•Corporate benefits and free car parking.
•Working across borders (20 days per year).
•Paid Parental Time Off (PPTO).
•Employee Status: Regular.
•VISA Sponsorship: Flexible.
•Work Arrangements: Hybrid.
