Senior Quality Engineer
Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team.
Let's look together at your first challenge with us!
Scope of work:
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.
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).
Ownership of launch coordinator role within Quality Operations (QO) oversight, for Launch Excellence product(s) for which he/she is responsible.
Depending on the individual situation, the Quality Project Associate is accountable for:
Ownership of quality systems and SOPs (eg. Regulatory Filing Management), to ensure the process is efficient, effective and compliant.
- Design the process and define roles and responsibilities
- Act as a quality system contact person during regulatory inspections
- Managing routine and complex continuous improvement projects and corrective and preventive actions for these quality systems
- Knowledge management of requirements, best practices and interdepartmental
Profile:
- Master’s Degree – Scientific discipline (eg. Pharmacy, Biomedical Sciences, Bio-engineer, …)
- You have a quality mindset
- You are pragmatic
- You have an excellent analytical and problem-solving skills
- You have an excellent oral and written communication skills and social skills
- You have a scientific knowledge and skills
- Languages: fluent in Dutch and English
- You have an excellent knowledge of cGMP, regulatory guidances and relevant medical device and combination product regulations.alignment
Must to have:
Ideally you 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.
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.
