Description
Due to a restructure within the company my client are currently looking for a QA Associate (QP Support/RP)to work in their Dublin office.This individual will work in the EU Quality Operations department which oversees commercial, clinical and medical device activities, contract manufacturing operations, supply chain operations and supplier quality functions performed on behalf of the company. This individual will work directly with the QP's supporting batch disposition activities in EU and may manage RP responsibilities in Dublin, Ireland. This individual will be responsible for the successful, timely completion of goals and objectives, which will strengthen the the company's EU Quality organisation.
RESPONSIBILITIES:
This position is responsible for executing, supporting and monitoring the quality performance of European quality systems according GMP & GDP standards.
The individual may be responsible for, but is not limited to:
* Reviewing and approving batch documentation, data, COAs and supporting QP functions to release products in EU
* Executing European quality systems and maintaining and improving quality metrics
* Writing & leading deviations, change controls, CAPA, investigations and non-conformance reviews, etc.
* Managing RP responsibilities, if in the license
* Drafting & coordinating TQAs and specifications
* Drafting drug product complaint reports and support any recall efforts in conjunction with QP
* Supporting the external auditing program and leading vendor audits.
* Supporting returns & destructions.
* Conducting training, including GMP/ GDP, for European staff
* Support Product Quality Review
* Participating in technology transfer, process scale-up, and process improvement projects.
Essential:
* Bachelor's degree in chemistry, biology or a related discipline
* Extensive experience working in Quality Assurance, Quality Control, and/or Qualified Person role to support the manufacturing of drugs, tablets, biologics, or devices.
* Experience conducting audits as lead auditor
* Must be able to prioritise and multitask in a stressful environment.
* Experience working with a Qualified Person or Responsible Person
Desired:
* Advanced degree in chemistry, biology or a related scientific discipline
* Quality experience in solid oral and parenteral biotech manufacturing (aseptic or sterile processing)
* Eligible to practise Qualified Person
* High level of professional competence. Preferably demonstrated by objective certification (e.g. Certified Quality Auditor).
If you are interested in this great opportunity and have the relevant skill set an experience please contact me Anna Mooney or apply below with a CV.