Quality Project Associate

Job title:

Quality Project Associate

Company

House of Talents

Job description

IntroductieScience 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 learning moments 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.Work is important; however, we also attach great value to a healthy dose of fun@work! Triggered? Let’s meet!”JobomschrijvingThis project is part of the QO Launch Excellence department, which is the independent product-oriented quality organization that has certain responsibilities concerning validation, registration and implementation within the site. Each QPA is assigned one or more specific Launch Excellence product(s) for which he/she is responsible.ValidationAct 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
• DHF

RegistrationThe 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 meeting.
• Performing compliance checks of the registration dossiers of the different markets versus the site practice

ImplementationEnsure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets.Profiel

• Master Degree – Scientific discipline (eg. Pharmacy, Biomedical Sciences, Bio-engineer, …)
• Plus if you already have 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.
• Excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.
• 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

Aanbod

• Freelance or as consultant on our payroll!

Will you become one of us?

• Monthly gross salary
• Net allowance with a maximum of €150
• Company car + fuel card
• Mobile phone subscription
• Group and hospitalisation insurance
• 12 days extra off due to a 40-hour working week + 20 legal holidays
• Meal vouchers + eco vouchers
• Training opportunities

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 maybe we will meet very soon! Solliciteer nu

Expected salary

Location

Breendonk, Antwerpen

Job date

Mon, 11 Aug 2025 02:27:15 GMT

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