This 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.
- 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)
- Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filings
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
- DHF
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
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 guidance and relevant medical device and combination product regulations