Senior CSV QA Specialist

Job Description

Drive GMP compliancelead riskbased 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 this handson 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 riskbased approach to validation.

Welcome to the team

At our company we aspire to be the premier research-intensive biopharmaceutical company. Were 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 companys 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

• Bachelors 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

Our benefits are very competitive and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance.

• 355 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.

For questions about this vacancy

Please send an email including the vacancy number and job title to the following email address:

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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