KS-0554
Location: , Kansas
Description: Ksearch is looking of KS-0554 right now, this occupation will be designated in Kansas. More complete informations about this occupation opportunity please read the description below. For a multinational pharmaceutical company we are looking for a Qualified Person Clinical Lot Release .
Scope:
Ensure compliant and efficient release of clinical materials, ensuring compliance g with cGMP legal and regu! latory requirements and the Quality Manual requirements.
Description of main activities:
- Release Clinical materials ensuring fully compliance with cGMP legal and regulatory requirements and the Quality Manual requirements.
- Ensure that systems are in place for having efficient Clinical materials release process interfacing with Clinical supply, QA GCP function, TDQA and site QA.
- Support the Core Project Team for ensuring a seamless IMP release.
- Ensure proper information channel are established from site Quality and TDQA to QA IMP release group.
- Maintain current knowledge of international regulatory and legislative requirements and trends to lead decision on IMP release.
Report to Global Head QA Development.
Professional/Technical Requirements:
- Microbiologist, Chemist or Pharmacist (MSc or Ph.D. from accredited Technical University) or appro! priate education and experience in pharmaceutical industry.
- Qualified Person.
- Minimum of 7 years in Quality Assurance and Quality Control and/or in a GMP regulated environment within the pharmaceutical industry.
- Minimum of 3 years in release of IMP.
- Excellent interpersonal and leadership skills.
- Quality driven, Analytical mindset, Strong communication and negotiation skills.
- .
If you were eligible to this occupation, please email us your resume, with salary requirements and a resume to Ksearch.
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This occupation will be started on: Tue, 03 Sep 2013 15:10:42 GMT