Quality Project Associate
Il y a 2 mois
**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
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