Over de vacature

A rare opportunity to build and lead your own practice inside a top-tier international platform.

A leading international law firm with a strong, well-established presence in Amsterdam is looking to significantly expand its technology, data and intellectual property offering, and is seeking an established Partner to spearhead this growth. This is a genuine platform play: the firm has the international network, client relationships and investment appetite to support a partner who wants to bring across (or build) a market-leading IP/IT practice, rather than simply slot into an existing one.

The Opportunity

This is a rare chance for a partner with a strong, portable IP/IT practice to essentially build their own group within an established, well-resourced international firm. You'll have full backing to grow a team around you, immediate access to a global client base spanning technology, life sciences, financial services and industrials, and genuine autonomy over how the practice is shaped and positioned in the market. The firm's international network means you'll be plugged into cross-border mandates from day one, working alongside colleagues across Europe, the US and Asia on IP litigation, technology transactions, data protection, AI governance and digital regulatory matters.

What makes this exciting:

• Genuine platform to build, not just join - you'd be shaping the strategy, team structure and client base of the practice yourself.
• Instant international reach - access to a global referral network and existing multinational clients who need IP/IT support in the Netherlands.
• Strong entrepreneurial backing - real investment appetite for lateral partners bringing a book of business or a team.
• Amsterdam as a hub - a market with growing demand around AI regulation, NIS2, GDPR/data protection, and digital transformation work.
• Autonomy and lockstep flexibility - compensation structures designed to reward practice growth and business generation.

What we're looking for:

• A partner with a strong, portable IP/IT practice and an established client following, ideally with cross-border experience.
• Deep expertise across some combination of IP litigation/prosecution, technology transactions, data protection, cybersecurity (NIS2) and/or AI regulatory advisory.
• A track record of business development and team leadership, with genuine ambition to build a practice rather than maintain one.

Over de vacature

**Overview

About the role:

You will provide operational support to the credit rating analysts by preparing committee materials, managing documentation, assisting QA, tracking reports, and coordinate with global operations team. This role requires strong data management skills, attention to detail, Microsoft Office skills, communication skills, and experience in regulated environments or workflow controls will be beneficial.

You will report into Associate Director, Rating Operations, London.

About the Rating Operations team:

The Rating Operations department is a part of the Credit Ratings (Analytics) side of AM Best. Our mission is to ensure that the organization continues to meet its regulatory requirements and sets the highest standards for good compliance and risk management. We ensure that our systems and processes are regularly reviewed to achieve maximum efficiency. We do this by acting as an interface between Analytics and Technology to identify and execute improvements that help us better achieve our aims.Ensuring that key performance indicators and metrics are produced on a regular basis to promote process development and aid senior management in the effective oversight of the organization.

Responsibilities

• Assist the analytical team in the process of developing rating committee presentations and ensuring accurate post committee documentation on a timely basis.

• Development of rating committee presentation quality metrics and management reports.

• Complete pre- and post-rating committee documentation in accordance with corporate policies and procedures.

• Assisting with the Quality Assurance (QA) process by preparing draft QA review sheets.

• Ensure that all company rating related documents are obtained on a timely basis, while overseeing compliance with document retention policies and procedures.

• Assist analysts with preparation of analytical worksheets.

• Assist with scheduling rating meetings in accordance with corporate policies and procedures.

• Overseeing the Credit Report process, ensuring that reports are published on time by monitoring the relevant mailboxes, performing tracker updates and updating correspondence logs.

• Proactively work with the Operations teams in Asia-Pacific and the US offices to ensure that a seamless level of support is provided to rating analysts globally.

  Skills

• Data entry and data management experience e.g. updating trackers, databases, etc.

• Developed workflow systems and quality controls a plus

• Experience working in a highly regulated industry a plus

• Knowledge of Microsoft office

• Exceptional attention to detail and highly organized

• Solid written and oral communication skills

• Strong customer service focused attitude towards both internal and external stakeholders; desire to assist the department in accomplishing goals

• Ability to support multiple groups concurrently

• Bachelor's degree preferred

  Role Type: Permanent Contract- Full time

  Hours: 35 hours, 5 days a week

  Workplace type: Hybrid**

Over de vacature

*Please note before applying: Only candidates with a valid work permit for the Netherlands will be considered for this role. This role does NOT offer sponsorships options.

• As QA Specialist, you will provide quality oversight for the validation and lifecycle management of equipment, automation and information systems. You will review technical documentation, advise different departments on GMP requirements and ensure that quality and compliance considerations are incorporated into technical decisions.
  Your main responsibilities include: - Reviewing and approving *equipment, automation and information system validation documentation

• .

• Providing QA guidance regarding the design, characterization and validation of equipment and systems.
• Ensuring validation activities comply with *GMP, internal quality standards and regulatory requirements

• .

• Reviewing and approving technical changes to equipment, including parameter changes and like-for-like assessments.
• Reviewing changes to Maintenance & Engineering procedures, including preventive and corrective maintenance and changeover processes.
• Providing quality engineering support for testing strategies, investigations and technical quality issues.
• Supporting quality activities related to *devices and combination products

• and ensuring alignment with applicable GMP requirements.

• Representing QA in *Quality Risk Management (QRM)

• activities, including FMEA and other quality risk assessments.

• Reviewing Quality Risk Assessment reports and ensuring site activities remain aligned with corporate quality policies and strategies.
• Performing the final QA review of *technical change controls

• , ensuring assessments and required actions are complete.

• Acting as a QA subject-matter expert for technical changes and coordinating input from different Quality areas.

This is a position with a high level of independence and responsibility. You will work with minimal supervision and manage several assignments and processes simultaneously. You will independently determine the appropriate approach for your projects while working toward defined operational and project objectives. Ultimately, your work contributes to delivering validated systems that meet corporate, site and regulatory requirements. #

Requirements

Requirements - A *Master's degree

• in Engineering, Pharmaceutical Sciences, Process Technology or a comparable field.

• Approximately *5–8 years of professional experience within a GMP environment

• .

• Relevant experience with *equipment and automation validation

• .

• Strong knowledge of *GMP requirements

• .

• Experience with equipment, automation and/or information system validation.
• Knowledge of computerized system compliance requirements, including *EU GMP Annex 11 and FDA 21 CFR Part 11

• .

• Experience with Quality Risk Management tools such as *FMEA

• .

• Experience using statistical methods to support activities such as sampling plans and hypothesis testing.

Nice to have - Previous experience within the *pharmaceutical industry

• .

• Experience working with *nonconformances, CAPAs and Change Control

• .

Benefits

• A challenging work environment with excellent career development programs.
• For this role, the company offers a competitive salary package.
• Reimbursement of travel expenses is dependable on travel distance.
• 30 Holidays.
• contract through Undutchables.

Application Procedure

If you are interested in this vacancy, you can apply by clicking on the button above. By clicking on apply, you agree to our privacy commitment and terms and conditions . Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission. Curious about how the recruitment process works within Undutchables, click here to read more.

Over de vacature

Borg de kwaliteit en veiligheid van medicijnen als Data Specialist Geneesmiddelen en Registratie in Utrecht! In deze veelzijdige baan verwerk je cruciale farmaceutische gegevens en doorgroei je tot zelfstandig casemanager. Samen met een betrokken, divers team lever jij een directe bijdrage aan de betrouwbaarheid van de zorg in Nederland en Europa!

Wat bieden wij jou

• Salaris tussen € 3.333 en € 4.457 obv 36 uur!
• Pensioenopbouw vanaf dag 1!
• Tussen 28 en 36 per week!
• Inclusief 8,3% eindejaaruitkering conform CAO Rijk
• Opdracht voor een jaar met kans op verlenging!
• 8,33% vakantiegeld!

Wie ben jij
Jij bent een nauwkeurige, communicatieve aanpakker met affiniteit voor data, ICT-systemen en procesverbetering. Je bent flexibel en schakelt makkelijk in een veranderende werkomgeving. Wat neem je mee?

• MBO+/HBO werk- en denkniveau.
• Enige jaren relevante werkervaring in een administratieve rol, bij voorkeur in dataverwerking.
• Goede beheersing van de Nederlandse en Engelse taal (mondeling en schriftelijk).
• Kennis van medische terminologie (bijv. opgedaan in de zorg, apotheek of drogisterij) is een sterke pré.
• Ervaring met werken in verschillende ICT-systemen.

Wat ga je doen
Als Data Specialist Geneesmiddelen en Registratie (officieel Regulatory Data Officer) op de afdeling Regulatory Datamanagement (RDM) ben je de onmisbare schakel bij de verwerking van nieuwe regulatoire aanvragen van de farmaceutische industrie. Jij zorgt voor het tijdig en correct invoeren en controleren van gegevens, zodat collega-beoordelaars inhoudelijk aan de slag kunnen.

Jouw dagelijkse werkzaamheden bestaan uit:

• Verwerken, controleren en accorderen van farmaceutische data in het bedrijfssysteem.
• Beheren van afdelingsmailboxen en Europese communicatiekanalen.
• Schakelen met aanvragers uit de farmaceutische industrie en internationale registratieautoriteiten.
• Signaleren van knelpunten en actief meedenken over proces- en systeemverbeteringen.
• Zelfstandig afhandelen van registratieprocedures, planning en validatie na jouw doorgroei naar casemanager.

Waar ga je werken
Je gaat aan de slag bij het College ter Beoordeling van Geneesmiddelen (CBG) op kantoor in Utrecht (Graadt van Roggenweg). Het CBG beoordeelt en bewaakt de werkzaamheid en veiligheid van medicijnen voor mens en dier. Je komt terecht in het diverse en collegiale team RDM (22 collega's), waar een open sfeer heerst en iedereen voor elkaar klaarstaat. Er wordt hybride gewerkt: je ontmoet je collega's regelmatig op kantoor in Utrecht, maar hebt ook de flexibiliteit om vanuit huis te werken.

Sollicitatie
Wil jij als Data Specialist Geneesmiddelen en Registratie bijdragen aan veilige medicijnen voor iedereen? Solliciteer direct met jouw goed onderbouwde CV en motivatiebrief!