Posted on Jul 11, 2021 by Real Staffing Group
The company offers Drug development and manufacturing and clinical trial and commercial packaging technology service to the pharmaceutical industry.
Main purpose of job:
The role is to implement and execute tasks relating to QP duties and certification activities associated with manufacturing processes/activities performed under IMP, MIA and veterinary licences. This role is a Senior QP role and will take a lead role in the company QP oversight, advising QP's on site and being a point of escalation for the QP group.
- Maintain compliance with GMP and customer expectations as defined in Quality Agreements, HPRA/Ireland legal framework, HPRA licences and EU GMP Directives/Guidelines.
- Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
- Support the sites clinical and commercial activities including Third Party release.
- To review Batch Manufacturing Documents to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant).
- To review Batch Documents for all operations.
- To certify Medicinal Products for use in the EU and outside the EU (where relevant).
- To undertake audits in EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP
- To provide advice and guidance to staff and Customers regarding QP requirements within the EU.
- To keep up to date with the requirements of the national regulatory authorities across the EU and rest of world (where relevant).
- Experienced in QP certification activities associated with investigational and commercial medicinal products.
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with both EU directives (2001/83/EC and 2001/20/EC) and local HPRA legal requirements
- Experienced in EU GMP audits (QP audits) of third country manufacturing and testing facilities
- Exposure to multiple dosage forms
- Experience in the review of deviation investigation and use of applicable investigation tools
- Experienced in working across multiple facilities as part of a global organisation
- Experience in internal and external manufacturing environments
For immediate consideration apply with an up to date CV. Not sure yet? No CV ready? Get in touch for more info.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales