Een inhoudelijke gedreven RA Manager op het gebied van klinisch onderzoek...

Deze internationale dienstverlenende organisatie is werkzaam in de farmaceutische industrie waar zij proberen om op een maatschappelijk verantwoordelijke manier hun kennis en expertise in te zetten tegen een eerlijke prijs. De medewekers van de organisatie maken het verschil in de markt doordat ze intrinsiek gemotiveerd zijn in het doen van hun werk. Cultuur kenmerken van de organisatie zijn informeel, toegankelijk en open minded. Recent heeft de organisatie een koerswijziging doorgevoerd, waard...

In de functie van RA Manager wordt er een beroep gedaan op jouw projectmanagement skills voor internationale en complexe variaties en registraties van dossiers. Je draagt zorg voor een volledig dossier conform de geldende wet- en regelgeving en begeleidt lopende registratieprocedures en variaties zowel Europees als nationaal (CP/MRP/DCP). Het uitvoeren en ondergaan van dossier audits behoort tot jouw taken en verantwoordelijkheden. Je zorgt voor een tijdige opvolging richting de interne en exter...

• hbo of wo opleiding, bij voorkeur richting Farmacie, (bio-) medische wetenschappen of biologie; • minimaal 5 jaar relevante ervaring in een Regulatory functie; • meerdere jaren werkervaring in Clinical Regulatory; • werkervaring binnen GMP; • sociaal, toegankelijk en gedreven; • uitstekende beheersing van de Engelse taal in woord en geschrift; • goede beheersing van de Nederlandse taal in woord en geschrift....

Challenging position within an inspiring, inclusive and respectful working environment...

The organization produces and exports a broad range of pharmaceuticals for patients throughout the world. At their production sites in Amsterdam and Brussels, they prepare a broad range of medicines derived from blood plasma. These products are used for a large number of disorders, many of which life-threatening. This position will be part of the QC Support team which is one of the two QC departments within the organization. These teams support QC operations with validation, maintenance and ca...

Our client is looking for an experienced QC Senior Systems Officer with knowledge about laboratory Information Management Systems (LIMS) to support the QC Support Equipment, Facility and Systems team in the build and introduction of the new LIMS system. You will build different parts of the LIMS system and will be involved in building different systems- and instrument interfaces. Furthermore, you are responsible for gathering the systems requirements and you will review required validation docum...

• preferably HBO with at least 5 years of experience in a Pharmaceutical laboratory and cGMP environment • familiar with Pharmaceutical QC testing • broad knowledge in LIMS-, ELN, SDMS Systems • experience with Business Analyses, Infrastructure, Software, Database, Software Systems Architecture • broad experience with equipment validation guidelines and rules • good communication and negotiation skills to operate in multidisciplinary teams • stress resistant, flexible, independent, pro-act...

An overall interim quality role to cover the site quality management for internal and external stakeholders...

Our client is an international pharmaceutical company specialized in the development, production and marketing of high-quality veterinary products. Their veterinary medicines and animal nutrition are mainly sold to veterinarians. They are active in 45 countries worldwide, with their own sales organization in 19 different European countries. They are a growing organization that emphasizes the desire to make a difference within a pleasant working culture. This position is vacant in Oudewater, the ...

In the role of QP you will support Group Quality CMO management in the definition, development, implementation and ongoing review of appropriate Key Performance Indicators (KPI’s) for senior management and monitor effectiveness across external CMO sites. You need to review the PQS (Pharmaceutical Quality System) and work with the site and Group Quality department to develop the PQS needed to manage CMO’s and operate in accordance with EU GDP requirements. As a QP you ensure that EU GDP requireme...

• Master’s degree in Pharmacy or equivalent • QP registration conform article 29 directory 81/851/EEG • over 5 years of experience in Quality Assurance • extensive demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling and investigations experience. • thorough knowledge of pharmaceutical manufacturing, packaging, testing and distribution processes and associated global regulatory GMP/GDP requirements. • experience of hosting...

Challenging and responsible position within a growing organisation ...

Our client is a medical device company which is founded in 1989 in The Netherlands. The mission of the organisation is to produce and sell copper Intrauterine Contraceptive Devices (IUD’s). This organization assures that their products may be used safely and that the products functions according to their intended use. Their product obtained the CE Marking of Conformity in 1996 and renewed it ever since. Within this organization there are short communication lines and a lot of challenging project...

As a Quality Assurance and Regulatory Affairs Officer you will be part of a small team who is responsible for the set-up, maintenance and improvement of the quality and regulatory required systems. These systems ensure that the company is able to fulfil the best quality and regulatory requirements for its products. In consultation with top management and experts this team will establish, implement and maintain processes for the quality management system. Together with your colleagues you will be...

• at least a bachelor’s degree and academic experience • experience within the medical device industry • good analytical and system skills • excellent communication skills, both internally and externally • excellent language skills in English as well as in Dutch • driven, self-starting and collaborative ...

Challenging Business Development position within an ambitious and growing organisation...

Our client is a fast-growing contract development organisation for the pharmaceutical industry. They assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. The organisation provides a comprehensive and integrated portfolio of molecule-to-medicine development and manufacturing services. They are operating from six sites in Europe, the headquarters is situated in Belgium. In the position of Corporate Business Development ...

As a Corporate Business Development Director, you will secure and retain business for all the Business Units through consultative, proactive sales and marketing activities. Your primary focus will be on marketing and selling their enhanced value propositions: you will seek for synergies between the different Business Units and position the organisation as a primary or preferred service provider. You will have direct responsibility for global prospection and assigned key accounts. Moreover, you w...

• master’s degree or PhD in Science or Business • minimum 10 years of experience in Business Development at C-level • proven track record of successfully pitching for new business • working experience in global pharma of early phase biotech market • you have a visibly demonstrate care for customers • you are a true motivator; you build and sustain cooperative working relationships and you are able to work effectively with colleagues in a variety of settings   ...

Challenging Management Team role within an international and fast growing organization....

Or client, Pivot Park Screening Centre, is an organization specialized in the scientific research. They provide highly regarded screening assessments and research programs. Their long-standing experience in an early drug discovery and state-of-art High Troughput Screening infrastructure provides their partners with the best confirmed leads. The High Troughput Screening (HTS) is a widely applied approach to find starting points for the development of new medicines. The organization are continuous...

The purpose of this position is to develop and implement an international growth strategy for the organization. Based on facts, data and analyses, you formulate a strategic plan in which you are not only responsible for the drafting, but also for implementation. The Global Business Development Director will also segment the market and focus in particular on the opportunities offered by Asia (Japan) and United States. The Global Business Development Director is responsible for managing and develo...

• university degree or higher with a preference for a Phd, Pharmacy, biology or chemical background • a minimum of 7 years of experience within an international sales position • knowledge off, affinity with and understanding of the pharmaceutical R&D field • a network in the Asian or American pharmaceutical market is recommended • demonstratable acquisition results, excellent negotiation skills, data-driven and market-oriented • strong conceptual capacity to translate organizational develop...

Uitdagende en veelzijdige kwaliteitsfunctie...

Onze opdrachtgever produceert en exporteert een breed assortiment geneesmiddelen voor patiënten over de hele wereld. Vanuit de ‘state of the art’ productielocaties in Amsterdam en Brussel bereiden zij een breed scala aan geneesmiddelen uit bloedplasma. De productie vindt plaats onder de hoogste veiligheidseisen. Deze medicijnen worden gebruikt voor een groot aantal aandoeningen, waarvan vele levensbedreigend zijn. Daarnaast stellen zij kennis en infrastructuur ter beschikking van diverse partner...

In de rol van QA Project Specialist ben je direct verantwoordelijk voor het uitvoeren van change control projecten. Je draagt zorg voor het borgen van Master Data door het beheren van het data management kwaliteitssysteem. Je participeert in projecten en change controle trajecten, daarbij vertegenwoordig je de afdeling op het gebied van validatie vereisten. Ook zorg je dat de strategieën en vereisten adequaat zijn vertaald in aanpassingen in documenten voor processen en systemen en begeleidt de ...

• afgeronde hbo- of wo-opleiding; • minimaal 2 jaar werkervaring in een QA functie binnen een cGMP werkomgeving; • aantoonbare kennis en ervaring met validatie en testmethoden; • zelfstandig, communicatief vaardig en sociaal; • goede beheersing van de Engelse taal in woord en geschrift; • kwaliteitsbewust, stressbestendig en secuur. ...

Challenging opportunity as Rayon Manager / International organisation...

Our client is a global biopharmaceutical organisation, led by a unique strategy that combines the reach of resources with the entrepreneurial spirit of a biotech organisation. They work hard to deliver innovative medicines for their patients with life-threatening diseases. They are active in the field of Oncology, Cardiovascular, Immunoscience and Fibrosis. The organisation is known for an inclusive culture and pays extra attention to the professional development and their work-life balance. Cur...

As Rayon Manager Cardiovascular you are responsible for the sales and market share development of a direct oral anti-coagulant (DOAC). You will implement the strategy on first line account level. It will be your responsibility to implement this strategy within different accounts, with a main focus on delivering the messages to their key customers in the first line. Also, you will build on new relations through different activities. In addition, you will work closely together with a cross-functio...

• Bachelor’s degree or higher with a commercial direction • at least 2 years of successful experience as an Accountmanager / Rayon Manager • experience with and examples in strong Key Account Management, preferably experience in cardiovascular, project management and first-line approach • demonstrated capability to analyze and have a solution-oriented approach • ability to translate agreed strategy into an operational action plan with clear timelines • fluent use of Microsoft Office, Excel...

Challenging position within an inspiring, inclusive and respectful working environment...

The organisation produces and exports a broad range of pharmaceuticals for patients throughout the world. At their production site in Amsterdam, they prepare a broad range of medicines derived from blood plasma. These products are used for a large number of disorders, many of which life-threatening. This position will be part of the QC Support team, which is one of the two QC departments within the organisation. These teams support QC operations with validation, maintenance and calibration of eq...

Our client is looking for an experienced QC Senior Equipment Officer to support the QC Support Equipment Validation team in the introduction and (re)validation of new and existing laboratory equipment. You will perform assessments to select the required and preferred QC laboratory system and supplier. Based upon the analytical samples and test requirements, specifications, procedures and Pharmacopoeia monographs. You are also involved in the investment procedure in order to buy the new equipment...

• preferably a Bachelor degree with at least 5 years of experience in a Pharmaceutical laboratory and cGMP environment (QC or R&D) • familiar with Pharmaceutical QC testing conform Pharmacopoeia monographs (Ph. Eur and USP) • broad experience with writing and reviewing of QC equipment validation documents for both analytical, chemical and microbiological test equipment • experience with Trackwise, Empower, Chromeleon, SAP, ICT procedures and LIMS • good communication and negotiation skills t...

Uitdagende en afwisselende functie binnen een unieke organisatie...

Onze opdrachtgever produceert en exporteert een breed assortiment geneesmiddelen voor patiënten over de hele wereld. Vanuit de ‘state of the art’ productielocatie in Amsterdam bereiden zij een breed scala aan geneesmiddelen uit bloedplasma. De productie vindt plaats onder de hoogste veiligheidseisen. Deze medicijnen worden gebruikt voor een groot aantal aandoeningen, waarvan vele levensbedreigend zijn. Daarnaast stellen zij kennis en infrastructuur ter beschikking van diverse partners. Dit doen ...

In de rol van QA Lead Auditor ben je verantwoordelijk voor het opzetten, leiden en uitvoeren van in- en externe audits in binnen- en buitenland. Je controleert of partijen in compliance zijn met de gestelde eisen en met de geldende wet- en regelgeving. Daarnaast ben je altijd opzoek naar mogelijkheden tot verbetering. Je zal je richten op het interne audit management en de deelname in het Audit Comité, waarbij je let op de planning, uitvoering, rapportage, follow-up en de jaarrapportage. Naast h...

• afgeronde bachelor- of masteropleiding; • meerdere jaren relevante ervaring in de producerende farmaceutische industrie (QA, QC, productie); • ervaring als Lead Auditor en gekwalificeerd als Internal Auditor; • certificering als Lead Auditor of bereid om deze certificering te behalen; • kennis van GxP en Farmaceutische Kwaliteit Systemen, alsmede van farmaceutische wet- en regelgeving; • kwaliteitsbewust, flexibel en stressbestendig; • goede beheersing van de Nederlandse en Engelse taal ...