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Quality Assurance Manager

Leinster   •  Negotiable  •  Permanent, Full time


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
  • Posted: 10th June 2022
  • Expires: 8th July 2022

Cpl Life Sciences

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