Unique opportunity to start-up the Belgian branch of a strong worldwide network....

BelgaSearch is focused on and committed to delivering recruitment and outsourcing solutions for the Belgian Life Sciences sector. This start-up is initiated by the French (www.cdgconseil.com) and Dutch (www.derksenderks.nl) members of Inrals (www.inrals.com), the strong worldwide network of first class agencies devoted to the Life Sciences. BelgaSearch is an independent agency with its own P&L and management. By recruiting and delivering the best permanent and interim management professionals fo...

You are responsible for the day-to-day operations and P&L of the company. After a short period of getting to know the network and the shareholders, you will engage with the markets, acquire assignments, recruit, and select permanent candidates, take care of the communication with clients, candidates and the market and the financial aspects of the organisation. The outsourcing business will be taken care of by a strong separate company that is being set up and will be run by separate staff. The...

• Bachelor’s degree • at least 5 years of experience in recruitment and the Belgian Life Sciences industry • entrepreneurial core and a strong sales and business development drive, to get BelgaSearch running • high energy to get things done in a qualitative way • motivated in sales and marketing, looking forward to bringing in clients and serving them perfectly • capable of overseeing what is needed strategically and for the daily operations at the same time • strong ethical moral values ...

Temporary position for 12 months at a pharmaceutical company...

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a motivated...

As an Regulatory Operations Associate you will be responsible to ensure timely preparation and submission of correspondence and applications to regulatory agencies, tracking and planning of such and document conformance to global publishing standards and style manuals. You will also be responsible for timelines and own resource management. You will participate in extended teams/projects/teams and ensure timely internal communication regarding regulatory filing status. In the position you will be...

• at least a Bachelor degree • some experience in Regulatory affairs • proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members • good written and oral communication skills in English • high integrity with respect to maintenance of proprietary, confidential information • highly accurate and organized, oversees support activities • affinity to work with IT systems and a problem solving mentality • comes up with improvements by tak...

Technical support and a major contribution to the analysis of Corona Virus...

Our client is a global organization with an entrepreneurial spirit. They are driven and work hard to distribute In Vitro Diagnostics products across Europe, Africa and the Middle East. It is a somewhat smaller organization with a hands-on mentality and definitely not a 9 to 5 mindset. They have an open culture in which there is always room for a joke and personal input. They supply a complete package of tests for Coronavirus throughout Europe and the rest of the world. They provide laboratory PC...

As a Product Specialist PCR you are responsible for all product related questions or complaints for 7 different products. You will be working closely together with the Product Manager PCR, with whom you will be responsible for the product presentations. In addition, you will give (online) operator training to end-users (hospitals) and distributors. As an amiable person, you are able to listen carefully and respond to the needs of the customer. You will also provide assistance for installation an...

• HLO degree (BSc Laboratory degree) • at least 3 years of experience with PCR tests in a clinical lab • familiar with multiple systems • proactive, flexible, positive mindset and team player • not a 9 to 5 mentality • experience as a Product Specialist is preferred • fluent in English (good communication skills in German, French, or Chinese is a plus) ...

Temporary position for approximately 1 year in the pharmaceutical industry...

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is in Leiden but has a tight line all around the world. To support the compliance activities, we would lik...

As an Associate PV Compliance/ Quality Systems Manager you will support the continuous monitoring of PV Compliance, submission timeliness and quality metrics. This includes the detection of negative patterns and trends in close collaboration with internal and external stakeholders (Regulatory Affairs, Quality Assurance, Business Partners). Furthermore, you will support the preparation of PV metrics reports and presentations that include performance indicators that provide feedback to functional ...

• more than 3 years of experience within Pharma, Quality and/or Compliance • global experience and working with European Drug Safety Officers (DSOs) preferred • pharmacovigilance and PV Safety Database experience required • experience in performing Root Cause Analysis required • knowledgeable about PV legislation required • strong leadership skills, team player, global mindset • ability to work effectively in a matrix setting to resolve issues and achieve common goals • excellent listenin...

Een verantwoordelijke en zelfstandige positie als leidinggevende in een ambitieuze en groeiende onderneming...

Onze opdrachtgever levert als onafhankelijke en groeiende onderneming farmaceutisch maatwerk voor specifieke patiëntenbehoeften, waardoor er zorg wordt gedragen voor een doelmatige geneesmiddelenvoorziening. Zij zetten zich in om geneesmiddelen met een medische noodzaak beschikbaar te maken en beschikbaar te houden. Dit zijn in bepaalde gevallen geneesmiddelen die voor een specifieke patiëntengroep of indicatie onmisbaar zijn. Op locatie ontwikkelt, produceert en registreert onze opdrachtgever h...

Als Manager van de afdeling QC geef je leiding aan 25 (senior) analisten en één of meer team leads. Je bent eindverantwoordelijk voor de kwaliteit en tijdigheid van alle activiteiten van de afdeling. De afdeling voert routinematige analyses uit op grondstoffen, tussen- en eindproducten. Je werkt zelfstandig, bewaakt het overzicht en levert resultaten. Met je helikopterview houd je overzicht en draag je zorg voor de juiste uitvoering en tijdige rapportage van analyses en communiceer je binnen de ...

• relevante hbo- of wo-opleiding, bij voorkeur in Chemistry; • minimaal drie jaar ervaring op het gebied van QC; • ervaring in een leidinggevende positie; • inhoudelijke kennis van en relevante ervaring in de farmaceutische industrie, ervaring in een productieomgeving is een pre; • zelfstandig, gedreven en resultaatgericht; • uitstekende communicatieve vaardigheden, zowel in woord als geschrift. ...

Zelfstandige positie voor een accurate en kwaliteitsgerichte QA Support Officer ...

Onze opdrachtgever behoort tot een wereldwijd netwerk van bedrijven dat een gezamenlijk doel dient om medicijnen te ontwikkelen die van toegevoegde waarde zijn voor patiënten en zorgverleners over de hele wereld. Het bedrijf, met het hoofdkantoor gevestigd in het Verenigd Koninkrijk, heeft inmiddels een netwerk in meer dan 120 landen in Afrika, Azië, Oceanië, Canada, Europa, Latijns-Amerika en het Midden-Oosten. Het productenpakket bestaat voornamelijk uit receptgeneesmiddelen maar ook uit een a...

Functie In deze functie ondersteun je de QP’s in het vrijgifteproces. Je rapporteert aan de Head of Quality. De voornaamste focus is het proces rondom de vrijgifte van de producten. Hierbij kan je denken aan werkzaamheden zoals de controle van de inkomende documenten en het voorbereiden van de dossiers, die essentieel zijn bij het vrijgeven van de producten. Daarnaast heb je de dagelijkse taak om de Quality Assurance-activiteiten te verwerken in het Quality Management System (QMS) voor het vol...

• mbo- of hbo-diploma bij voorkeur in de richting van Life Sciences; • minimaal 2 jaar werkervaring in de farmaceutische industrie; • aantoonbare ervaring met GMP en GDP; • kennis van ‘third party management’ en de ‘risk management principles’ (gewenst); • gedreven, verantwoordelijk ingesteld en met sterke communicatieve vaardigheden; • beheersing van de Nederlandse en Engelse taal, in woord en geschrift. ...

Global pharmacovigilance position as the first contact point for all Affiliate Drug Safety Officers ...

The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They have everything in house from research, development, manufacturing and warehousing to sales and marketing. It is their hope to change tomorrow’s world and to improve the lives of individuals by providing innovative medicines in areas of health, where there is an urgen...

In the role as Affiliate Support Manager you will be responsible for the day-to-day interactions with and guidance of the Affiliate Drug Safety Officers (DSOs) to ensure all affiliate local pharmacovigilance systems, processes and procedures are compliant, efficient and in line with global/regional regulatory requirements, policies and procedures. You are going to serve as a first point of contact for all global DSOs, monitor affiliate performance, train affiliate staff, ensure audit and inspect...

• at least a bachelor’s degree • at least 7 years of relevant experience, or 5 years including a master’s degree • in-depth knowledge of regulatory requirements • understanding of all aspects of pharmacovigilance and related disciplines • strong problem-solving skills • good professional and interpersonal communication skills; both oral and written in English • willingness to travel up to 50% ...

An interesting regulatory position at an international pharmaceutical organisation ...

The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They do everything themselves, from research, development, manufacturing and warehousing to sales and marketing. It is their hope to change the world of tomorrow and to improve the lives of individuals by providing innovative medicines at locations where there is an urgent...

As a Regulatory Intelligence Associate, you are responsible for providing insights in the available regulatory information. You will monitor new regulatory information, and search for specific information on request. You will also provide technological expertise in support of regulatory intelligence activities. To do this, you will be responsible for maintaining and improving regulatory knowledge sharing systems and maintaining relationships with strategic technical business partners. Furthermor...

• health science diploma or equivalent • experience within RA or other related experience within the pharmaceutical industry • experience with searching for information and managing IT systems • strong problem-solving skills • proven innovation skills • ability to multi-task across multiple projects and deliverables • good professional and interpersonal communication skills, both oral and written in English...

Temporary position for an interesting pharmacovigilance project for three to six months....

Our client has been a leading provider of risk management and compliance services to the Life Sciences industry since 2008. These include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety, and quality and compliance auditing and systems. They want to make the process from development to market faster, better and smarter. The headquarter of this organization is located in Ireland, with European operations in...

As a Pharmacovigilance Specialist you will work on projects and tasks assigned by the unit Team Lead. You will ensure the delivery of projects/tasks is in accordance with the clients’ needs as per the contractual agreements and procedures. Furthermore, you will follow and achieve KPIs of the department. You will constantly seek for the clients’ and internal feedback and take this into consideration to improve the efficiency and quality of the work within the assigned projects. Therefore, you wil...

• Bachelor’s degree or graduate in Pharmaceutical Sciences or related fields; advanced degree (e.g. Masters) preferable • at least one year of experience working in a medical or safety department with demonstrable expertise of medical terminology • detailed knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.) • experience with a safety database is desirable • ability to delegate and oversee work of staff and an excellent team player • organizational...

Temporary six months contract for a project in batch record review for drug substance...

This organisation is a contract manufacturing organisation located at the Bioscience Parc in Leiden. They provide service in manufacturing for commercial products as well as clinical products. They have an open and professional culture where everyone is working hard, but also finds time to have some fun. They recently took on a project for which they have to expand their Quality Department. This is why the organisation would like to hire new professionals to help out. ...

As the Batch Review/Release Officer you will be involved in the project for producing the COVID-19 vaccine in a large manufacturing site. For now it will be a temporary project where you will work with a team to manage and improve the process following government and organisational quality guidelines. Your main responsibility and focus is to get the quality approval for drug substances of batch record review. It is also your responsibility to prepare, evaluate and follow-up a monthly management ...

• bachelor’s degree in Life Sciences (Biotechnology or related) or comparable level through experience • minimum of three years working experience within a GMP- or CMO environment • hands-on experience in pharmaceutical operations or a laboratory is a preference • knowledge of European and US’ rules and regulations on GMP • experience with pharmaceutical quality management systems • experience with Lean management and 6 Sigma methodology • good knowledge of Dutch and English in speaking an...