We are looking for an experienced Qualified Person for one of the leading global vaccine production companies based in Leiden.
Are you a registered QP with pharma experience and are you comfortable in both an R&D and commercial environment? Are you ready for a next challenge in high end pharmaceutical development?
Please read along...
As a Quaified Person you act as one of the releasing QPs for Vaccine Products for which this company is either the Marketing authorization holder or is filed as Release Site. You provide QA support for multiple External Manufacturers supplying product to or exporting through the EMEA region. Contribute to the overall development, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecule products.
The position requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance. As well as the ability to manage multiple and/or complex External Manufacturers. Demonstrated ability to take ownership for and lead the resolution of Quality and Compliance issues.
Execute the duties and roles of a QP:
- Interact with regulatory inspectors.
- Evaluate, approve and sign regulatory document with respect to vaccine registrations.
- Have End to End quality oversight of the supply chain for vaccine products released on-site.
- Review and approve quality complaints and investigations for the vaccine products in the portfolio,
- Approval of change controls, deviations and non- conformity of vaccine products
- Can act as the EU QP in escalations and may take decisions on further escalations and recalls
- Interacts with OMCL and NCL when needed
Basically this means you will:
- Serve as a contact point within the QA organization of other departments and the external manufacturer with respect to quality relevant subjects.
- Ensure that all relevant QA related concerns at the external manufacturer’s sites.
- Ensure that the manufacturing operations at the external manufacturer site run smoothly from a QA point of view and in a compliant manner.
- Review batch documentation of products in scope prior to release and completion of the Lot release protocol.
- Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is necessary.
- Review and monitor customer complaints in the respective database. Interaction with the complaint handling department of the external manufacturer to follow-up on investigations; secondary review of serious complaints.
- Level of education: academic
- Work experience: 5+ years
- QP Experience (preferred) are able to become a QP in the short term
- Extensive (> 3 y) knowledge of GMP, specifically parenteral experience is preferred (QA and/or production)
- Able to connect easily, team worker, able to manage across cultures
- Amount of travel 10%
- English mandatory, other languages are a benefit
- Candidates must be living in the Netherlands and have a valid working visa
You will be offered a challenging job for a global leading company within pharmaceuticals.
Next to that you will be offered:
- Competative salary based on experience
- Annual Fixed Bonus
- 38 holidays per year
- Flexible working hours
Techniek & Engineering
T: +31 6 5148 9894
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