My pharmaceutical client, based in Belgium, is looking for a quality specialist to release IMPs and other drug products for clinical trials; as well as act as a consultant on QA activities within their plant. This is a 6 month contract that may well extend/go permanent.

Responsibilities will include:
 Acting as a QP for batch review and release, particularly for IMPs and products for Clinical Trials.
 Identifying, investigating and resolving quality and compliance issues.
 Managing the company quality systems.
 Managing review and release processes across the CMC and Clinical Supply aspects of the organisation.
 Writing and managing QA Agreements with CMOs.
 Providing guidance to CMC Development scientists.
 Acting as a project manager for process improvement initiatives.

Candidates must have:
 A life science degree or equivalent industry experience.
 Minimum 5 years pharmaceutical industry experience within quality assurance, including QA/compliance experience within IMP manufacturing and/or laboratories.
 Experience in conducting audits of customer sites/CMOs/other vendors, as well as involvement in regulatory authority inspections.
 Experience with solid and liquid dosage forms; sterile parenteral and/or biological product manufacturing experience is desirable
 Fluency in English, a working knowledge of German would be an asset; as would a certified/lead auditor qualification.

You do not need to be a QP under the EU permanent provisions for this role, but experience releasing IMPs or other drug products is highly desirableApply now