Senior CSV QA Specialist

Merck; Haarlem; On-site; EUR 60.000 - 80.000; Full time

Job summary

A leading biopharmaceutical company based in Haarlem is looking for a Senior CSV QA Specialist. This role involves driving GMP compliance, supporting manufacturing and logistics teams, and ensuring the quality oversight of computerized systems. Ideal candidates should have strong analytical and communication skills, along with practical experience in regulated environments. Attractive salary and benefits offered.

Benefits

Competitive salary

Year-end allowance

Health care insurance

Solid Pension Plan

Annual bonus

Travel allowance

Training and development opportunities

Qualifications

• 2+ years of experience delivering validated IT solutions.
• Knowledge of CSA, Annex 11, Annex 22 and GAMP5 regulations.
• Familiarity with quality systems in pharmaceutical or biotechnology environments.

Responsibilities

• Influence policies, procedures, and validation documents.
• Ensure computerized systems are validated and compliant.
• Support regulatory inspections and audits.

Skills

Communication skills

Analytical skills

Problem-solving skills

Project management

Education

Bachelor’s degree in IT, Engineering or related

Job description

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.

About the role

A great opportunity is open for a CSV Quality Assurance Specialist to join the global Digital & Data Quality (DDQ) team in Haarlem, 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 and support inspection readiness. Ideal candidates have practical CSV/QA experience in regulated environments, strong communication and influencing skills, and a risk‑based approach to validation.

Welcome to the team

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. As a Senior CSV QA Specialist, you will play a vital role in ensuring compliance with our company’s policies, procedures, and regulatory expectations.

Primary Responsibilities

• Actively influence the organizational future through your review and approval of policies, procedures and key validation documents, such as plans, protocols, requirements and reports.
• Help system owners to ensure procedures are followed and computerized systems are in a validated state (for example: deviation and incident management, change control, periodic review, backup/restore, system use and admin SOPs, disaster recovery and business continuity).
• In a fast changing business environment, act as a change driver to site processes within the global Quality Management System (QMS) framework.
• 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.
• Represent DDQ management in site and above-site meetings as needed.
• Support regulatory inspections and audits as needed.
• Work together with the business to resolve regulatory non-conformances for cGMP computerized systems in a way that ensures business efficiency and compliance.

Who You Are

• Bachelor’s degree (or equivalent experience), preferably in Information Technology, Engineering or a related field.
• At least two 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.
• 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 success. English language skills are a must, speaking Dutch (or the willingness to learn) a great asset.
• 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.

What we offer

• Competitive salary and a 3% year-end allowance.
• 35,5 days of leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Annual bonus based on own and company performance.
• Travel allowance for commuting.
• Numerous training, coaching and e-learning modules for long term job opportunities and development.