Quality Assurance Manager / Qualified Person (full EU right to work required)
Location: Dublin (Flexible home working)
*PLEASE NOTE TO APPLY FOR THIS ROLE, YOU MUST HAVE THE FOLLOWING;
Proven experience in a QA position or similar within a life sciences organisation
Auditing experience
GMP (Good manufacturing practice) experience
BSc. Degree in Life Sciences
People Management Advantage
Electronic Quality Management experience Advantage
I am looking for experienced Quality Assurance Managers / Qualified Person, as we have numerous of QP roles on across Europe, as we help to find the continents best launch experts capable of a forthcoming blockbuster launch. This follows significant success in the U.S with our client seeing more than a 40% growth in their product, which they are now launching across Europe. Hundreds of millions of pounds are being invested to ensure the roll out the launch plans are successful and delivered by a substantial team which we've helped them find various medical, compliance, market access, sales, digital, QPs and GM's so far.
Key responsibilities:
Playing a key role in supporting each stage of Europe-wide Quality Management System.
Support of data preparation for periodic review of the QMS and management review as appropriate
Supporting the redesign/management of the company Quality Management System
Ensuring good practices (GxP, QMS, SOPs) are adopted and implemented throughout
Providing Quality expertise and oversight
Acting as a Quality representative for all tasks in the Quality System Documents
Producing regular Quality Reports
Delivering Quality training to staff
Supporting the internal audit program by creating an internal audit schedule
Performing audits (internal, Contract Service Provider and Contract Manufacturing Organisations)
Managing independent auditors
Work in close partnership with the global Quality department and other cross functional partners to meet timelines and achieve targets.
Deputising for the Director of Quality as required
The purpose of this role will be to advise and oversee GMP compliance within the organisation. The post holder will be responsible for reviewing and approving key quality documents such as SOPs, testing documentation and manufacturing batch records.
This is an excellent opportunity to further your QA skills within an expanding biopharmaceutical company. If you would like to hear more, please apply within or send your CV to Jessica.anderson@cpl.com
- Agency: Cpl Life Sciences
- Reference: JO-2206-494387
Website: Cpl Life Sciences
- Posted: 10th June 2022
- Expires: 8th July 2022