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Qualified Person

Qualified Person
Amsterdam

For a client in Amsterdam I am looking for a Qualified Person for a project until April. This is regarding a position for two days a week.

In this position you are responsible for:
* To provide independent QA/QP oversight of all GxP activities performed.
* To oversee the controlled importation of unreleased finished product into the EU from third party countries.
* To perform QP release of influenza product(s) to market as required, to include commercial and clinical trials products. To provide oversight of the QA batch release operations and follow up actions associated with PTCs.
* To work with the QC Manager and provide QA oversight of the QC laboratories who perform QC testing.
* To ensure that appropriate quality standards and systems are in place, and applied across the site operations in accordance with regulatory requirements.
* You will be responsible for Accountable for final QP release of product to market, and you won't have direct reports.

What are the requirements?
* A degree or equivalent in a life science.
* The candidate should meet the requirements for EU Qualified Person.
* Substantial industry experience; vaccines, steriles and biological experience is preferable.
* A commercial outlook with attention to detail.
* A proactive approach which builds Quality & Compliance into processes.
* A track record in cementing teams, and delivering outstanding effectiveness from those teams.
* The ability to deal with complexity and uncertainty and to remain calm under pressure.
* A good track record with the FDA, MHRA, EMEA and other regulatory agencies.

Are you interested in this position and do you want to apply for this opportunity? Please do not hesitate to contact the consultant about this, Celine Stevens, at 020 522 1588 or at c.stevens(at)realstaffing.com.