Quality Project Associate

Il y a 5 mois

Antwerpen, Belgique Science Talents Temps plein

**Introduction**:
Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.

We are very open and communicative go-getters who are keen on results and quality.

To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.

Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry.

**Job description**:
As QPA, you will be responsible for validation, validation, registration and implementation for specific products:
Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings

Product Quality as the independent quality authority for product-related qualifications and validations of the assigned products.

Compliant and right first time product launches within Quality Operations (QO) oversight

**Registration**

The composition, production processes, specifications, analytical methods of the drug products are described in the registration dossiers of the different markets. The QPA is responsible to pursue regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved by participating in the following processes:

- Data verification and QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings
- Performing compliance checks of the registration dossiers of the different markets versus the site practice
- Regulatory change control process: Coordinate regulatory impact assessment for proposed product-related changes

**Validation**
- Act as quality authority in a consistent way, in compliance with cGMPs and current regulatory expectations, for the following qualification and validation documents:

- Process qualification/validation
- Method validation
- Filter validation
- Component qualification
- Raw material evaluation

**Implementation**

Ensure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets, and work with the technicians to update and/or launch the systems (RSS process, LIMS system, SAP, MBR, BRM etc).

**Profile**:
Master Degree - Scientific discipline (eg. Pharmacy, Biomedical Sciences, Bio-engineer,)

2 years of relevant experience in the pharmaceutical sector and/or medical device industry (or equivalent by acquiring a PhD) with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for (Bio-)Pharmaceutical products.
- Quality mindset
- Pragmatic
- Excellent analytical and problem solving skills
- Excellent oral and written communication skills and social skills
- Scientific knowledge and skills
- Languages: fluent in Dutch and English
- Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations

**Offer**:
Will you become one of us? Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues We cannot wait to meet you Fill in the form below and we will reach out to you soon.

contract of indefenite duration, included:

- company car + fuel card
- Health insurance
- Meal vouchers of 8€ per day worked
- Net allowances
- Group insurance
- Smartphone subscription
- end of year bonus (13th month)
- Eco vouchers

  • Quality Project Associate

    Il y a 5 mois

    Antwerpen, Belgique Maandag Temps plein

    **Over de functie**: Als **Quality Project Associate** ben je verantwoordelijk voor drie belangrijke processen bij de productie van nieuwe farmaceutische producten. Zo ben je verantwoordelijk voor de regulatory CMC (= Chemistry, Manufacturing & Controls) conformiteit van de fabrieksprocessen met de reglementaire aanvragen. De samenstelling,...

  • Quality Projects Associate

    Il y a 5 mois

    Antwerpen, Belgique Belgatech Temps plein

    place - Antwerp- , Belgiquework_history Experience 0 à 2 ans CDI - dans le secteur Life Sciences**L'offre**: Om onze toenemende groei te versterken, zijn we op zoek naar een Quality Projects Associate. Meer specifiek, een georganiseerde en resultaatgerichte teamspeler die de puntjes op de i zet. Jouw verantwoordelijkheden - Kwaliteitscontrole van...

  • Quality Projects Associate

    Il y a 5 mois

    Antwerpen, Belgique pi life sciences Temps plein

    **L'offre**: **Responsibilities**: - Quality Review of Validation Documentation, Change Records and Procedures - Regulatory Impact assessments - Coordination of Regulatory Submissions and Responses - Support in Quality Management Systems (Validation, QRM, Change Management, Regulatory Systems ) **Profil recherché**: Your skillset - Minimum Master's degree...

  • Quality Associate

    Il y a 6 mois

    Antwerpen, Belgique Johnson & Johnson Temps plein

    Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a **Quality Associate SM-API (M/F/X) **as member of our Quality team overseeing Small Molecule Active Pharmaceutical Ingredients (SM-API) based in Geel, Belgium. J&J Innovative Medicine Supply Chain Geel serves as Centre of Excellence for the...

  • Junior Business Associate

    Il y a 6 mois

    Antwerpen, Belgique CFOrent Temps plein

    **The perfect start for a career in finance**: The junior associate will tag along with a senior or partner in order to complete transactions. His role will be to assist in business transactions and analyze complex data. - learning opportunity, chance to grow, - Opportunity to work close with a finance & business associates - Maintaining efficient and...

  • Quality project engineer

    il y a 4 semaines

    Antwerpen, Belgique Maandag Temps plein

    Over de functie Als Quality Project Engineer ben je verantwoordelijk voor het ontwikkelen, implementeren en verbeteren van kwaliteitsprocessen en -procedures. Je voert tests en kwaliteitscontroles uit op producten en implementeert nieuwe systemen en methoden om de kwaliteit en veiligheid van onze producten te waarborgen. Daarnaast zorg je ervoor dat alle...

  • Quality project engineer

    il y a 4 semaines

    Antwerpen, Belgique Maandag Temps plein

    Over de functie Als Quality Project Engineer ben je verantwoordelijk voor het ontwikkelen, implementeren en verbeteren van kwaliteitsprocessen en -procedures. Je voert tests en kwaliteitscontroles uit op producten en implementeert nieuwe systemen en methoden om de kwaliteit en veiligheid van onze producten te waarborgen. Daarnaast zorg je ervoor dat alle...

  • (Senior) Associate Scientist

    Il y a 5 mois

    Antwerpen, Belgique Johnson & Johnson Temps plein

    Temporary contract of 11 months. The Small Molecule Method Development (SMMD) group of J&J Innovative Medicine is recruiting for a **(Senior) **Associate Scientist **, located in Beerse, Belgium. As **(Senior) **Associate Scientist **, you will join the Small Molecule Method Development (SMMD) group within the Analytical Development department, which is...

  • Associate QA Csc

    Il y a 5 mois

    Antwerpen, Belgique Johnson & Johnson Temps plein

    Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a Quality Assurance Associate to strengthen the post-certification team! The post-certification team is part of the Quality Assurance Clinical Supply Chain team and responsible to guarantee the quality and compliance of our investigational products after they have been...

  • QA Associate Cryo Lab Car-t

    Il y a 7 mois

    Antwerpen, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Associate for the CAR-T Cryo Lab in Europe. The position will be based in Beerse. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune...

  • QA Lab Associate Car-t

    Il y a 6 mois

    Antwerpen, Belgique Johnson & Johnson Temps plein

    The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab associate for the CAR-T hub in Europe. The position will be based in Beerse Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. The...

  • QA Associate

    il y a 2 semaines

    Antwerpen, Belgique Johnson & Johnson Temps plein

    This position will be based at our Geel site in Belgium. Change lives for the better. THE OPPORTUNITY Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA Associate - QA Lab (M/F/X) as member of our Quality team overseeing the Quality Control laboratories Small Molecule Active...

  • Sales Associate

    Il y a 5 mois

    Antwerpen, Belgique Soeur Temps plein

    **Presentation of the company**: Soeur is a French womenswear brand founded in 2008 by two sisters, Domitille and Angélique Brion, a complementary duo guided by the desire to dress all women, of all generations. They draw their inspiration from their memories, their travels, and a stylistic vision that is indelibly French. The result is delicate, subtly...

  • Sales Associate

    Il y a 5 mois

    Antwerpen, Belgique Soeur Temps plein

    **Presentation of the company**: Soeur is a French womenswear brand founded in 2008 by two sisters, Domitille and Angélique Brion, a complementary duo guided by the desire to dress all women, of all generations. They draw their inspiration from their memories, their travels, and a stylistic vision that is indelibly French. The result is delicate, subtly...

  • Quality Manager

    Il y a 5 mois

    Antwerpen, Belgique Emerson Temps plein

    The Quality Manager is tasked with maintaining and enhancing the Quality Management System (QMS) to uphold compliance with ISO 9001, API 6D, and PED certifications. They cultivate a quality-centric culture throughout the organization by employing effective communication, training, and the implementation of specific quality engineering techniques....

  • Product Artwork Operational Excellence Associate

    Il y a 5 mois

    Antwerpen, Belgique Johnson & Johnson Temps plein

    The Product Artwork Operational Excellence Associate will partner with the different functions within PA, Packaging CoE, Global Regulatory and Compliance, Business & Technology Quality, Pack sites and vendors to identify, develop and implement new opportunities and/or innovative technologies to optimize processes and systems. He/She will strengthen...

  • Finance & Business Associate

    Il y a 5 mois

    Antwerpen, Belgique CFOrent Temps plein

    Outstanding career opportunities for ambitious finance professionals The finance & business associate operates independently, though in collaboration with a (Finance Business) partner on different projects. He will have the opportunity to work with, and for the client while providing added value. His role will be to support the company in setting up and...

  • Associate Assay Development Scientist

    Il y a 5 mois

    Antwerpen, Belgique Science at Work Temps plein

    **Wat ga je doen?**: Our client is a growing research laboratory specializing in the field of immune oncology. They mainly collaborate with pharmaceutical and biotechnology companies in the research and development of innovative new drugs for the treatment of cancer. Currently we are looking for an Assay development scientist. You are responsible for the...

  • Quality Coordinator

    Il y a 5 mois

    Antwerpen, Belgique Pauwels Consulting Temps plein

    In het kortantwerpen bediende, freelancer 40 uur per week - Robbe SmetTalent Acquisition Specialist Life Sciences 0032498672831 - **Quality Coordinator**: Pharma & Sciences - Quality & Compliance For big Pharmaceutical companies within the region of Antwerp and Brussels, we are looking for Quality Coordinators with at least a first experience in Quality....

  • Quality Coordinator

    Il y a 5 mois

    Antwerpen, Belgique Pauwels Consulting Temps plein

    In het kortantwerpen bediende, freelancer 40 uur per week - Robbe SmetTalent Acquisition Specialist Life Sciences 0032498672831 - **Quality Coordinator**: - Pharma & Sciences - Quality & Compliance For big Pharmaceutical companies within the region of Antwerp and Brussels, we are looking for Quality Coordinators with at least a first experience in Quality....