Job Description
You will be responsible for managing Quality Control and Certification activities related to assigned medicinal products in the EU and other relevant markets. This is a contract position with an hourly rate.
We are seeking a highly motivated Qualified Person to join our team in Dublin, Ireland. As a full-time Qualified Person, you will have the opportunity to develop your skills and expertise in this exciting field.
The Qualified Person will be responsible for overseeing Quality Control and Certification activities associated with assigned medicinal products in the EU and other relevant markets.
Daily Responsibilities:
● Ensure quality control and certification of all assigned medicinal products within the EU and other relevant markets, confirming that each batch has been manufactured and inspected according to its Marketing Authorization (MA) requirements and Good Manufacturing Practice (GMP) principles and any other applicable laws.
● Product Certification & Release must adhere to 2001/83/EC (as amended).
● Qualified Person and batch release activities should comply with EU GMP Annex 16: Certification by a Qualified Person and Batch Release.
● Identify any product quality or quality system deficiencies.
● Review and approve Annual Product Quality Reviews for assigned medicinal products.
● Ensure timely investigation and resolution of deviations and Out-of-Specification (OOS) results.
● Monitor, manage, and report adverse events for the EU and other relevant markets to regulatory authorities.
Educational Requirements:
* Bachelor's degree or equivalent in a science-related field, such as biology, chemistry, pharmacy, or biochemical engineering.
* Eligibility 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.