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Senior Quality Assurance Manager

Leinster   •  Negotiable  •  Permanent, Full time

Senior Quality Assurance Manager (full EU right to work required)

Location: Dublin based (Office 3 Days can be flexible)

Contract Type: Permanent Full time


6+ years proven experience in a QA position or similar within a pharmaceutical industry

Auditing experience - Required

GMP (Good manufacturing practice) experience - Required

QMS experience - Required

Management experience Required

Pharmaceutical manufacturing experience - Required

BSc. Degree in Life Sciences _ Required

GDP (Good distribution practice) Advantage

Postgraduate - Advantage

People Management Advantage

Electronic Quality Management Systems experience Advantage

I am looking for experienced Quality Assurance Managers / Qualified Person, as I am currently recruiting for a Senior QA Manager to join a Global team environment, as I help to find the continents best launch experts capable of a forthcoming blockbuster launch. This a key role within the Global Technical Operations department headquartered in Dublin and will be responsible for the management of the APIL Quality Management System to support European distribution & QP batch release. 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 as a company have helped them find various medical, compliance, market access, sales, digital, QPs and GM's so far.

Key responsibilities:

Working alongside the Executive Director Quality and delegating where required.

You will be supporting the development, implementation, and maintenance of the Europe-wide Quality Management System ensuring that all compliance is delivered to all relevant regulatory standards.

Support GMP activities at approved CMOs as required

Supporting relevant customer complaint investigations ensuring quality service to customer and also timely closure

Support the preparation, delivery and coordination of training on GxP, QMS, SOPs and processes.

Support the development and reporting of quality metrics

Alongside this you will also be supporting the Operation and maintenance of the Document Management system to ensure control of SOPs, records and other documents.

Ensuring the management of quality systems such as Deviation, CAPA, Change Control, Training, Complaints, Internal Audit, Vendor Management, and Risk Management arecompliant & escalated as appropriate.

Implementation and maintenance of robust document & record retention / storage process

Preparation & processing of quality documents & logs as required by the QMS and with supporting the vendor qualification program to ensure quality oversight of GxP Vendors.

Be a key member of company audit team during regulatory or customer audits.

Become a key part of the global Quality department and other cross functional groups to ensure the application of both the corporate and APIL Quality Management system.

The purpose of this role will be to work alongside Executive Director Quality and manage the development and maintain compliance within the organisation, along with supporting the team, implementing and delegating where needed. The post holder will be responsible for the management of the APIL Quality Management System to support European distribution & QP batch release.

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-2206-495123
  • Posted: 17th June 2022
  • Expires: 15th July 2022

Cpl Life Sciences

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