Job Description
You will be responsible for the management of the QP release and certification activities associated with assigned drug product for the EU & other relevant markets. This is an hourly rate contract.
We are on the lookout for an enthusiastic Qualified Person for a productive team based in Dublin. Growing your career as a full Time Qualified Person is an amazing opportunity to develop exceptional skills. If you are strong in decision-making, presentation and have the right experience for the job, then apply for the position of Qualified Person at Morgan McKinley today.
The Qualified Person will be responsible for the management of the QP release and certification activities associated with assigned drug product for the EU & other relevant markets.
Daily Responsibilities:
● QP release and certification of all assigned products within the EU & other relevant markets; assuring that the DP batch has been manufactured and checked in accordance with the requirements of its MA and in accordance with the principles and guidelines of GMP & any other legal requirements.
● Product Certification & Release should be performed in accordance with 2001/83/EC (as amended).
● QP and batch release activities should be in accordance with EU GMP Annex 16: Certification by a Qualified Person and Batch Release.
● Identify deficiencies in product quality and quality systems.
● Review and approval of Annual Product Quality Reviews for assigned drug product.
● Ensure that all deviations and OOS results are investigated with timely CAPA.
● Review, manage and report adverse events for the EU and other relevant markets to health authorities.
Educational Requirements:
1. BSc or equivalent in a sciences discipline, biology, chemistry, pharmacy, or biochemical engineering.
2. Eligible to act as a Qualified Person as defined in 2001/83/EC (amended) and 2001/82/EC (amended).
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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